Combined oral contraceptives (COCs) are commonly classified into generations, referring to their order of development in history. This discussion may also help identify some key features in a variety of products. According to EMA, the first generation of combined oral contraceptives, which made use of a high concentration of oestrogen only, were those invented in the 1960s. In the second generation of products, progestogens were introduced into the formulation while the concentration of oestrogen was reduced. Starting from the 1990s, the progression in the development of combined oral contraceptives has been directed towards varying the type of progestogen incorporated. These products are referred as the third and fourth generation.
Hormonal oral contraceptives (HOCs) interact with hormonal changes in the menstrual cycle in females to prevent ovulation, and hence achieve contraception. In a 28-day menstrual cycle, there are the proliferative phase, ovulation, and then the secretory phase.
Progesterone and Oestrogen, either in combination or with Progesterone-only, are the active pharmaceutical ingredients found in a hormonal oral contraceptive formulation. These medications are orally administered for systemic absorption to exert their effects. An artificially enhanced level of Progesterone throughout the menstrual cycle inhibits the pituitary secretion of FSH and LH such that their actions in stimulating follicular development and ovulation are prevented. Similarly, a boosted Oestrogen level activates the negative feedback mechanism in reducing FSH secretion from pituitary and therefore prevents follicular development. In the absence of a developed follicle, ovulation cannot occur so that fertilisation is made impossible and contraception is achieved. In comparison, Progesterone is more efficacious than Oestrogen not only because of its additional action in impeding LH, but also its ability to modulate the cervical mucus into sperm-repellent.
Estrogen was originally included in oral contraceptives for better cycle control (to stabilize the endometrium and thereby reduce the incidence of breakthrough bleeding), but was also found to inhibit follicular development and help prevent ovulation. Estrogen negative feedback on the anterior pituitary greatly decreases the secretion of FSH, which inhibits follicular development and helps prevent ovulation.
Another primary mechanism of action of all progestogen-containing contraceptives is inhibition of sperm penetration through the cervix into the upper genital tract (uterus and fallopian tubes) by decreasing the water content and increasing the viscosity of the cervical mucus.
The estrogen and progestogen in combined oral contraceptive pills have other effects on the reproductive system, but these have not been shown to contribute to their contraceptive efficacy:
Insufficient evidence exists on whether changes in the endometrium could actually prevent implantation. The primary mechanisms of action are so effective that the possibility of fertilization during combined oral contraceptive pill use is very small. Since pregnancy occurs despite endometrial changes when the primary mechanisms of action fail, endometrial changes are unlikely to play a significant role, if any, in the observed effectiveness of combined oral contraceptive pills.
Combined oral contraceptive pills have been somewhat inconsistently grouped into "generations" in the medical literature based on when they were introduced.
Combined oral contraceptive pills are a type of oral medication that were originally designed to be taken every day at the same time of day in order to prevent pregnancy. There are many different formulations or brands, but the average pack is designed to be taken over a 28-day period (also known as a cycle). For the first 21 days of the cycle, users take a daily pill that contains two hormones, estrogen and progestogen. During the last 7 days of the cycle, users take daily placebo (biologically inactive) pills and these days are considered hormone-free days. Although these are hormone-free days, users are still protected from pregnancy during this time.[medical citation needed]
Some combined oral contraceptive pill packs only contain 21 pills and users are advised to take no pills for the last 7 days of the cycle. Other combined oral contraceptive pill formulations contain 91 pills, consisting of 84 days of active hormones followed by 7 days of placebo (Seasonale). Combined oral contraceptive pill formulations can contain 24 days of active hormone pills followed by 4 days of placebo pills (e.g. Yaz 28 and Loestrin 24 Fe) as a means to decrease the severity of placebo effects. These combined oral contraceptive pills containing active hormones and a placebo/hormone-free period are called cyclic combined oral contraceptive pills. Once a pack of cyclical combined oral contraceptive pill treatment is completed, users start a new pack and new cycle.
Most monophasic combined oral contraceptive pills can be used continuously such that patients can skip placebo days and continuously take hormone active pills from a combined oral contraceptive pill pack. One of the most common reasons users do this is to avoid or diminish withdrawal bleeding. The majority of women on cyclic combined oral contraceptive pills have regularly scheduled withdrawal bleeding, which is vaginal bleeding mimicking users' menstrual cycles with the exception of lighter menstrual bleeding compared to bleeding patterns prior to combined oral contraceptive pill commencement. As such, a study reported that out of 1003 women taking combined oral contraceptive pills approximately 90% reported regularly scheduled withdrawal bleeds over a 90-day standard reference period. Withdrawal bleeding usually occurs during the placebo, hormone-free days.[medical citation needed] Therefore, avoiding placebo days can diminish withdrawal bleeding among other placebo effects.[medical citation needed]
For 21-tablet packs, the general instruction is to take one tablet daily for 21 days, followed by a 7-day blank interval without taking hormonal oral contraceptives before initiating another 21-tablet pack. For 28-tablet packs, the 1st tablet from a new pack should be taken on the next day when the 28th tablet from an old pack was finished. While the 7-day blank period does not apply to 28-tablet packs, they will likely include tablets in distinctive colours indicating that they have an alternate amount of active ingredients, otherwise inactive ingredient or folate supplement only. The instruction for 91-tablet pack follows that of 28-tablet packs with some colour-distinguishable tablets which contain different amounts of medicine or supplement.
To acquire immediate contraceptive effects, the initiation of hormonal oral contraceptive dosing is recommended within the 1st-5th day from menstruation in order to discard other means of contraception. Specific to Progesterone only pills, even if dosing is initiated within five days, backup contraception is suggested in the first 48 hours since the first pill. In the case of dosing initiated after the 5th day from menstruation, effects usually take place after seven days and other contraceptive methods should remain in place until then.
If used exactly as instructed, the estimated risk of getting pregnant is 0.3% which means that about 3 in 1000 women on combined oral contraceptive pills will become pregnant within one year. However, typical use of combined oral contraceptive pills by users often consists of timing errors, forgotten pills, or unwanted side effects. With typical use, the estimated risk of getting pregnant is about 9% which means that about 9 in 100 women on combined oral contraceptive pills will become pregnant in one year. The perfect use failure rate is based on a review of pregnancy rates in clinical trials, and the typical use failure rate is based on a weighted average of estimates from the 1995 and 2002 US National Surveys of Family Growth (NSFG), corrected for underreporting of abortions.
Several factors account for typical use effectiveness being lower than perfect use effectiveness:
For instance, someone using combined oral contraceptive pills might have received incorrect information by a health care provider about medication frequency, forgotten to take the pill one day or not gone to the pharmacy in time to renew a combined oral contraceptive pill prescription.
Combined oral contraceptive pills provide effective contraception from the very first pill if started within five days of the beginning of the menstrual cycle (within five days of the first day of menstruation). If started at any other time in the menstrual cycle, combined oral contraceptive pills provide effective contraception only after 7 consecutive days of use of active pills, so a backup method of contraception (e.g. condoms) must be used in the interim.
The effectiveness of combined oral contraceptive pills appears to be similar whether the active pills are taken continuously or if they are taken cyclically. Contraceptive efficacy, however, could be impaired by numerous means. Factors that may contribute to a decrease in effectiveness:
In any of these instances, a backup contraceptive method should be used until hormone active pills have been consistently taken for 7 consecutive days or drug-drug interactions or underlying illnesses have been discontinued or resolved. According to the US Centers for Disease Control and Prevention (CDC) guidelines, a pill is considered "late" if a user takes the pill after the user's normal medication time, but no longer than 24 hours after this normal time. If 24 hours or more have passed since the time the user was supposed to take the pill, then the pill is considered "missed". CDC guidelines discuss potential next steps for users who missed their pill or took it late.
The placebo, or hormone-free, week in the 28-day pill package simulates an average menstrual cycle, though the hormonal events during a pill cycle are significantly different from those of a normal ovulatory menstrual cycle. Because the pill suppresses ovulation (to be discussed more in the Mechanism of action section), birth control users do not have true menstrual periods. Instead, it is the lack of hormones for a week that causes a withdrawal bleed. The withdrawal bleeding that occurs during the break from active pills has been thought to be reassuring, a physical confirmation of not being pregnant. The withdrawal bleeding is also predictable. Unexpected breakthrough bleeding can be a possible side effect of longer term active regimens.
Since it is not uncommon for menstruating women to become anemic, some placebo pills may contain an iron supplement. This replenishes iron stores that may become depleted during menstruation. As well, birth control pills, such as combined oral contraceptive pills, are sometimes fortified with folic acid as it is recommended to take folic acid supplementation in the months prior to pregnancy to decrease the likelihood of neural tube defect in infants.
If the pill formulation is monophasic, meaning each hormonal pill contains a fixed dose of hormones, it is possible to skip withdrawal bleeding and still remain protected against conception by skipping the placebo pills altogether and starting directly with the next packet. Attempting this with bi- or tri-phasic pill formulations carries an increased risk of breakthrough bleeding and may be undesirable. It will not, however, increase the risk of getting pregnant.
Starting in 2003, women have also been able to use a three-month version of the pill. Similar to the effect of using a constant-dosage formulation and skipping the placebo weeks for three months, Seasonale gives the benefit of less frequent periods, at the potential drawback of breakthrough bleeding. Seasonique is another version in which the placebo week every three months is replaced with a week of low-dose estrogen.
A version of the combined pill has also been packaged to eliminate placebo pills and withdrawal bleeds. Marketed as Anya or Lybrel, studies have shown that after seven months, 71% of users no longer had any breakthrough bleeding, the most common side effect of going longer periods of time without breaks from active pills.
While more research needs to be done to assess the long term safety of using combined oral contraceptive pills continuously, studies have shown there may be no difference in short term adverse effects when comparing continuous use versus cyclic use of birth control pills.
The hormones in the pill have also been used to treat other medical conditions, such as polycystic ovary syndrome (PCOS), endometriosis, adenomyosis, acne, hirsutism, amenorrhea, menstrual cramps, menstrual migraines, menorrhagia (excessive menstrual bleeding), menstruation-related or fibroid-related anemia and dysmenorrhea (painful menstruation). Besides acne, no oral contraceptives have been approved by the US FDA for the previously mentioned uses despite extensive use for these conditions.
The cause of PCOS, or polycystic ovary syndrome, is multifactorial and not well-understood. Women with PCOS often have higher than normal levels of luteinizing hormone (LH) and androgens that impact the normal function of the ovaries. While multiple small follicles develop in the ovary, none are able to grow in size enough to become the dominant follicle and trigger ovulation. This leads to an imbalance of LH, follicle stimulating hormone, estrogen, and progesterone. Without ovulation, unopposed estrogen can lead to endometrial hyperplasia, or overgrowth of tissue in the uterus. This endometrial overgrowth is more likely to become cancerous than normal endometrial tissue. Thus, although the data varies, it is generally agreed upon by most gynecological societies that due to the unopposed estrogen, women with PCOS are at higher risk for endometrial cancer.
To reduce the risk of endometrial cancer, it is often recommended that women with PCOS who do not desire pregnancy take hormonal contraceptives to prevent the effects of unopposed estrogen. Both combined oral contraceptive pills and progestin-only methods are recommended. It is the progestin component of combined oral contraceptive pills that protects the endometrium from hyperplasia, and thus reduces a woman with PCOS's endometrial cancer risk. Combined oral contraceptive pills are preferred to progestin-only methods in women who also have uncontrolled acne, symptoms of hirsutism, and androgenic alopecia, because combined oral contraceptive pills can help treat these symptoms.
Combined oral contraceptive pills are sometimes prescribed to treat symptoms of androgenization, including acne and hirsutism. The estrogen component of combined oral contraceptive pills appears to suppress androgen production in the ovaries. Estrogen also leads to increased synthesis of sex hormone binding globulin, which causes a decrease in the levels of free testosterone.
Ultimately, the drop in the level of free androgens leads to a decrease in the production of sebum, which is a major contributor to development of acne. Four different oral contraceptives have been approved by the US FDA to treat moderate acne if the patient is at least 14 or 15 years old, has already begun menstruating, and needs contraception. These include Ortho Tri-Cyclen, Estrostep, Beyaz, and YAZ.
Hirsutism is the growth of coarse, dark hair where women typically grow only fine hair or no hair at all. This hair growth on the face, chest, and abdomen is also mediated by higher levels or action of androgens. Therefore, combined oral contraceptive pills also work to treat these symptoms by lowering the levels of free circulating androgens.
Studies have shown that combined oral contraceptives are effective in reducing both inflammatory and non-inflammatory facial acne lesions. However, comparisons between different combined oral contraceptives have not been studied to understand if any brand is superior than the others. Oestrogen decreases sebum production by shrinking the sebaceous gland, increasing Sex hormone-binding globulin (SHBG) production to reduce unbound testosterone, and regulating LH and FSH levels. Studies have not shown that POPs are effective against acne lesions.
For pelvic pain associated with endometriosis, combined oral contraceptive pills are considered a first-line medical treatment, along with NSAIDs, GnRH agonists, and aromatase inhibitors. Combined oral contraceptive pills work to suppress the growth of the extra-uterine endometrial tissue. This works to lessen its inflammatory effects. Combined oral contraceptive pills, along with the other medical treatments listed above, do not eliminate the extra-uterine tissue growth, they just reduce the symptoms. Surgery is the only definitive treatment. Studies looking at rates of pelvic pain recurrence after surgery have shown that continuous use of combined oral contraceptive pills is more effective at reducing the recurrence of pain than cyclic use.
Similar to endometriosis, adenomyosis is often treated with combined oral contraceptive pills to suppress the growth the endometrial tissue that has grown into the myometrium. Unlike endometriosis however, levonorgestrel containing IUDs are more effective at reducing pelvic pain in adenomyosis than combined oral contraceptive pills.
In the average menstrual cycle, a woman typically loses 35 to 40 milliliters of blood. However, up to 20% of women experience much heavier bleeding, or menorrhagia. This excess blood loss can lead to anemia, with symptoms of fatigue and weakness, as well as disruption in their normal life activities. Combined oral contraceptive pills contain progestin, which causes the lining of the uterus to be thinner, resulting in lighter bleeding episodes for those with heavy menstrual bleeding.
Although the pill is sometimes prescribed to induce menstruation on a regular schedule for women bothered by irregular menstrual cycles, it actually suppresses the normal menstrual cycle and then mimics a regular 28-day monthly cycle.
Menstrual bleeding is not necessary in women who do not wish to conceive, therefore menstrual suppression may be implemented in women who do not want to have menstrual bleeding for convenience, gynecologic disorders, bleeding disorders or other medical conditions.
In the two types of hormonal oral contraceptives, only combined oral contraceptives can achieve amenorrhea, while POPs can only reduce the amount of blood. The method of using combined oral contraceptives for menstrual suppression is to skip the 7 placebo pills and continue taking active pills after the 21 active pills. This can be used in extended method or continuous method. For extended method, patients who take active pills for 3, 4, or 6 months and then take placebo pills for a period of time will more likely experience withdrawal bleeding. The interval can be decided by the patients according to their own preferences. For continuous method, people can take combined oral contraceptives for a year continuously without any placebo pills. In the first few months of extended or continuous use of combined oral contraceptives, unscheduled bleeding or spotting may occur. However, the bleeding or spotting is expected to resolve after a few months of use.
Menstrual suppression is commonly used for convenience especially when women go on vacation. It is also used for gynecologic disorders such as dysmenorrhea (commonly known as menstrual pain), symptoms related to premenstrual hormone change and excessive bleeding related to uterine fibroids. Patients can also benefit from menstrual suppression for bleeding disorders or chronic anemia.
The distinctive feature of hormonal oral contraceptives when compared to other contraceptive methods is that they are less invasive and do not interfere with sex. Conclusive data suggest that the failure rate of contraception in using hormonal oral contraceptives for the first year is 9% in typical use which allows missed doses, and <1% in perfect use. The efficacy of hormonal oral contraceptives in preventing pregnancy is high overall. Furthermore, the regular use of hormonal oral contraceptive tends to not only ease premenstrual syndrome, but also allow lighter and less painful menstruation. In addition, the association between a suppressed risk of developing ovarian cancer and hormonal oral contraceptive use is proven.
*The category should be assessed according to the severity of the condition.
Estrogen in high doses can increase risk of blood clots. All combined oral contraceptive pill users have a small increase in the risk of venous thromboembolism compared with non-users; this risk is greatest within the first year of combined oral contraceptive pill use. Individuals with any pre-existing medical condition that also increases their risk for blood clots have a more significant increase in risk of thrombotic events with combined oral contraceptive pill use. These conditions include but are not limited to high blood pressure, pre-existing cardiovascular disease (such as valvular heart disease or ischemic heart disease), history of thromboembolism or pulmonary embolism, cerebrovascular accident, and a familial tendency to form blood clots (such as familial factor V Leiden). There are conditions that, when associated with combined oral contraceptive pill use, increase risk of adverse effects other than thrombosis. For example, women with a history of migraine with aura have an increased risk of stroke when using combined oral contraceptive pills, and women who smoke over age 35 and use combined oral contraceptive pills are at higher risk of myocardial infarction.
Women who are known to be pregnant should not take combined oral contraceptive pills. Those in the postpartum period who are breastfeeding are also advised not to start combined oral contraceptive pills until 4 weeks after birth due to increased risk of blood clots. While studies have demonstrated conflicting results about the effects of combined oral contraceptive pills on lactation duration and milk volume, there exist concerns about the transient risk of combined oral contraceptive pills on breast milk production when breastfeeding is being established early postpartum. Due to the stated risks and additional concerns on lactation, women who are breastfeeding are not advised to start combined oral contraceptive pills until at least six weeks postpartum, while women who are not breastfeeding and have no other risks factors for blood clots may start combined oral contraceptive pills after 21 days postpartum.
It is generally accepted that the health risks of oral contraceptives are lower than those from pregnancy and birth, and "the health benefits of any method of contraception are far greater than any risks from the method". Some organizations have argued that comparing a contraceptive method to no method (pregnancy) is not relevant—instead, the comparison of safety should be among available methods of contraception.
Different sources note different incidence of side effects. The most common side effect is breakthrough bleeding. Combined oral contraceptive pills can improve conditions such as dysmenorrhea, premenstrual syndrome, and acne, reduce symptoms of endometriosis and polycystic ovary syndrome, and decrease the risk of anemia. Use of oral contraceptives also reduces lifetime risk of ovarian and endometrial cancer.
Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.
While lower doses of estrogen in combined oral contraceptive pills may have a lower risk of stroke and myocardial infarction compared to higher estrogen dose pills (50 μg/day), users of low estrogen dose combined oral contraceptive pills still have an increased risk compared to non-users. These risks are greatest in women with additional risk factors, such as smoking (which increases risk substantially) and long-continued use of the pill, especially in women over 35 years of age.
The overall absolute risk of venous thrombosis per 100,000 woman-years in current use of combined oral contraceptives is approximately 60, compared with 30 in non-users. The risk of thromboembolism varies with different types of birth control pills; compared with combined oral contraceptives containing levonorgestrel (LNG), and with the same dose of estrogen and duration of use, the rate ratio of deep venous thrombosis for combined oral contraceptives with norethisterone is 0.98, with norgestimate 1.19, with desogestrel (DSG) 1.82, with gestodene 1.86, with drospirenone (DRSP) 1.64, and with cyproterone acetate 1.88. In comparison, venous thromboembolism occurs in 100–200 per 100.000 pregnant women every year.
One study showed more than a 600% increased risk of blood clots for women taking combined oral contraceptive pills with drospirenone compared with non-users, compared with 360% higher for women taking birth control pills containing levonorgestrel. The US Food and Drug Administration (FDA) initiated studies evaluating the health of more than 800,000 women taking combined oral contraceptive pills and found that the risk of VTE was 93% higher for women who had been taking drospirenone combined oral contraceptive pills for 3 months or less and 290% higher for women taking drospirenone combined oral contraceptive pills for 7–12 months, compared with women taking other types of oral contraceptives.
Based on these studies, in 2012, the FDA updated the label for drospirenone combined oral contraceptive pills to include a warning that contraceptives with drospirenone may have a higher risk of dangerous blood clots.
A 2016 systematic review found low quality evidence that studies of combination hormonal contraceptives showed no large difference in weight when compared with placebo or no intervention groups. The evidence was not strong enough to be certain that contraceptive methods do not cause some weight change, but no major effect was found. This review also found "that women did not stop using the pill or patch because of weight change".
Some researchers question a causal link between combined oral contraceptive pill use and decreased libido; a 2007 study of 1700 women found combined oral contraceptive pill users experienced no change in sexual satisfaction. A 2005 laboratory study of genital arousal tested fourteen women before and after they began taking combined oral contraceptive pills. The study found that women experienced a significantly wider range of arousal responses after beginning pill use; decreases and increases in measures of arousal were equally common.
Current medical reference textbooks on contraception and major organizations such as the American ACOG, the WHO, and the United Kingdom's RCOG agree that current evidence indicates low-dose combined oral contraceptives are unlikely to increase the risk of depression, and unlikely to worsen the condition in women that are depressed.
Bradykinin lowers blood pressure by causing blood vessel dilation. Certain enzymes are capable of breaking down bradykinin (Angiotensin Converting Enzyme, Aminopeptidase P). Progesterone can increase the levels of Aminopeptidase P (AP-P), thereby increasing the breakdown of bradykinin, which increases the risk of developing hypertension.
Estrogen in oral contraceptives may increase thyroid binding globulin and decrease free T4. Thus, longer history of oral contraceptives use may be strongly associated with hypothyroidism, especially for more than 10 years. Also, a higher dose of thyroxine may be needed with oral contraceptives.
Other side effects associated with low-dose combined oral contraceptive pills are leukorrhea (increased vaginal secretions), reductions in menstrual flow, mastalgia (breast tenderness), and decrease in acne. Side effects associated with older high-dose combined oral contraceptive pills include nausea, vomiting, increases in blood pressure, and melasma (facial skin discoloration); these effects are not strongly associated with low-dose formulations.[medical citation needed]
Excess estrogen, such as from birth control pills, appears to increase cholesterol levels in bile and decrease gallbladder movement, which can lead to gallstones. Progestins found in certain formulations of oral contraceptive pills can limit the effectiveness of weight training to increase muscle mass. This effect is caused by the ability of some progestins to inhibit androgen receptors. One study claims that the pill may affect what male body odors a woman prefers, which may in turn influence her selection of partner. Use of combined oral contraceptives is associated with a reduced risk of endometriosis, giving a relative risk of endometriosis of 0.63 during active use, yet with limited quality of evidence according to a systematic review.
The availability of pharmaceutical products to the public is determined by the local governing body. In the US, the responsible organisation is the Food and Drug Administration (FDA). According to a press announcement in July 2023, a daily hormonal oral contraceptive was first made accessible to the public without a prescription. Although this drug class was approved for prescription use as early as in 1973, it took an additional 50 years to de-escalate its legal status. Such allowance is made plausible thanks to the demonstration of its safe and effective use by the general public, not needing any guidance from healthcare professionals. Ultimately, the governing body should act accordingly to applicants' evidence and update the local legislation.
Progesterone, given by injections, was first shown to inhibit ovulation in animals in 1937 by Makepeace and colleagues.
In March 1952, Sanger wrote a brief note mentioning Pincus' research to her longtime friend and supporter, suffragist and philanthropist Katharine Dexter McCormick, who visited the WFEB and its co-founder and old friend Hudson Hoagland in June 1952 to learn about contraceptive research there. Frustrated when research stalled from PPFA's lack of interest and meager funding, McCormick arranged a meeting at the WFEB in June 1953, with Sanger and Hoagland, where she first met Pincus who committed to dramatically expand and accelerate research with McCormick providing fifty times PPFA's previous funding.
In 1953, at Pincus' suggestion, Rock induced a three-month anovulatory "pseudopregnancy" state in twenty-seven of his infertility patients with an oral 300 mg/day progesterone-only regimen for 20 days from cycle days 5–24 followed by pill-free days to produce withdrawal bleeding. This produced the same 15% pregnancy rate during the following four months without the amenorrhea of the previous continuous estrogen and progesterone regimen. But 20% of the women experienced breakthrough bleeding and in the first cycle ovulation was suppressed in only 85% of the women, indicating that even higher and more expensive oral doses of progesterone would be needed to initially consistently suppress ovulation. Similarly, Ishikawa and colleagues found that ovulation inhibition occurred in only a "proportion" of cases with 300 mg/day oral progesterone. Despite the incomplete inhibition of ovulation by oral progesterone, no pregnancies occurred in the two studies, although this could have simply been due to chance. However, Ishikawa et al. reported that the cervical mucus in women taking oral progesterone became impenetrable to sperm, and this may have accounted for the absence of pregnancies.
Progesterone was abandoned as an oral ovulation inhibitor following these clinical studies due to the high and expensive doses required, incomplete inhibition of ovulation, and the frequent incidence of breakthrough bleeding. Instead, researchers would turn to much more potent synthetic progestogens for use in oral contraception in the future.
Pincus asked his contacts at pharmaceutical companies to send him chemical compounds with progestogenic activity. Chang screened nearly 200 chemical compounds in animals and found the three most promising were Syntex's norethisterone and Searle's noretynodrel and norethandrolone.
In December 1954, Rock began the first studies of the ovulation-suppressing potential of 5–50 mg doses of the three oral progestins for three months (for 21 days per cycle—days 5–25 followed by pill-free days to produce withdrawal bleeding) in fifty of his patients with infertility in Brookline, Massachusetts. Norethisterone or noretynodrel 5 mg doses and all doses of norethandrolone suppressed ovulation but caused breakthrough bleeding, but 10 mg and higher doses of norethisterone or noretynodrel suppressed ovulation without breakthrough bleeding and led to a 14% pregnancy rate in the following five months. Pincus and Rock selected Searle's noretynodrel for the first contraceptive trials in women, citing its total lack of androgenicity versus Syntex's norethisterone very slight androgenicity in animal tests.
Noretynodrel (and norethisterone) were subsequently discovered to be contaminated with a small percentage of the estrogen mestranol (an intermediate in their synthesis), with the noretynodrel in Rock's 1954–5 study containing 4–7% mestranol. When further purifying noretynodrel to contain less than 1% mestranol led to breakthrough bleeding, it was decided to intentionally incorporate 2.2% mestranol, a percentage that was not associated with breakthrough bleeding, in the first contraceptive trials in women in 1954. The noretynodrel and mestranol combination was given the proprietary name Enovid.
While these large-scale trials contributed to the initial understanding of the pill formulation's clinical effects, the ethical implications of the trials generated significant controversy. Of note is the apparent lack of both autonomy and informed consent among participants in the Puerto Rican cohort prior to the trials. Many of these participants hailed from impoverished, working-class backgrounds.
As of 2013, less than a third of countries worldwide required a prescription for oral contraceptives.
Although FDA-approved for contraceptive use, Searle never marketed Enovid 10 mg as a contraceptive. Eight months later, in February 1961, the FDA approved Enovid 5 mg for contraceptive use. In July 1961, Searle finally began marketing Enovid 5 mg (5 mg noretynodrel and 75 μg mestranol) to physicians as a contraceptive.
Although the FDA approved the first oral contraceptive in 1960, contraceptives were not available to married women in all states until Griswold v. Connecticut in 1965, and were not available to unmarried women in all states until Eisenstadt v. Baird in 1972.
Beginning in 2015, certain states passed legislation allowing pharmacists to prescribe oral contraceptives. Such legislation was considered to address physician shortages and decrease barriers to birth control for women. Pharmacists in Oregon, California, Colorado, Hawaii, Maryland, and New Mexico have authority to prescribe birth control after receiving specialized training and certification from their respective state Board of Pharmacy. As of January 2024[update], pharmacists in 29 states can prescribe oral contraceptives.
Before the mid-1960s, the United Kingdom did not require pre-marketing approval of drugs. The British Family Planning Association (FPA) through its clinics was then the primary provider of family planning services in the UK and provided only contraceptives that were on its Approved List of Contraceptives (established in 1934). In 1957, Searle began marketing Enavid (Enovid 10 mg in the US) for menstrual disorders. Also in 1957, the FPA established a Council for the Investigation of Fertility Control (CIFC) to test and monitor oral contraceptives which began animal testing of oral contraceptives and in 1960 and 1961 began three large clinical trials in Birmingham, Slough, and London.
In March 1960, the Birmingham FPA began trials of noretynodrel 2.5 mg + mestranol 50 μg, but a high pregnancy rate initially occurred when the pills accidentally contained only 36 μg of mestranol—the trials were continued with noretynodrel 5 mg + mestranol 75 μg (Conovid in the UK, Enovid 5 mg in the US).
In August 1960, the Slough FPA began trials of noretynodrel 2.5 mg + mestranol 100 μg (Conovid-E in the UK, Enovid-E in the US).
In May 1961, the London FPA began trials of Schering's Anovlar.
In October 1961, at the recommendation of the Medical Advisory Council of its CIFC, the FPA added Searle's Conovid to its Approved List of Contraceptives.
In December 1961, Enoch Powell, then Minister of Health, announced that the oral contraceptive pill Conovid could be prescribed through the NHS at a subsidized price of 2s per month.
In 1962, Schering's Anovlar and Searle's Conovid-E were added to the FPA's Approved List of Contraceptives.
The pill was approved by the US FDA in the early 1960s; its use spread rapidly in the late part of that decade, generating an enormous social impact. Time magazine placed the pill on its cover in April 1967. In the first place, it was more effective than most previous reversible methods of birth control, giving women unprecedented control over their fertility. Its use was separate from intercourse, requiring no special preparations at the time of sexual activity that might interfere with spontaneity or sensation, and the choice to take the pill was a private one. This combination of factors served to make the pill immensely popular within a few years of its introduction.
Because the pill was so effective, and soon so widespread, it also heightened the debate about the moral and health consequences of pre-marital sex and promiscuity. Never before had sexual activity been so divorced from reproduction. For a couple using the pill, intercourse became purely an expression of love, or a means of physical pleasure, or both; but it was no longer a means of reproduction. While this was true of previous contraceptives, their relatively high failure rates and their less widespread use failed to emphasize this distinction as clearly as did the pill. The spread of oral contraceptive use thus led many religious figures and institutions to debate the proper role of sexuality and its relationship to procreation. The Roman Catholic Church in particular, after studying the phenomenon of oral contraceptives, re-emphasized the stated teaching on birth control in the 1968 papal encyclical Humanae vitae. The encyclical reiterated the established Catholic teaching that artificial contraception distorts the nature and purpose of sex. On the other side Anglican and other Protestant churches, such as the Protestant Church in Germany (EKD), accepted the combined oral contraceptive pill.
The introduction of the birth control pill in 1960 allowed more women to find employment opportunities and further their education. As a result of women getting more jobs and an education, their husbands had to start taking over household tasks like cooking. Wanting to stop the change that was occurring in terms of gender norms in an American household, many films, television shows, and other popular culture items portrayed what an ideal American family should be. Below are listed some examples:
Several studies have suggested that reducing human population growth through increased access to contraception, including birth control pills, can be an effective strategy for climate change mitigation as well as adaptation. According to Thomas Wire, contraception is the 'greenest technology' because of its cost-effectiveness in combating global warming — each $7 spent on contraceptives would reduce global carbon emissions by 1 tonne over four decades, while achieving the same result with low-carbon technologies would require $32.
Teal S, Edelman A (December 2021). "Contraception Selection, Effectiveness, and Adverse Effects: A Review". JAMA. 326 (24): 2507–2518. doi:10.1001/jama.2021.21392. PMID 34962522. S2CID 245557522. https://doi.org/10.1001%2Fjama.2021.21392
"Guinea pigs or pioneers? How Puerto Rican women were used to test the birth control pill". The Washington Post. ISSN 0190-8286. Archived from the original on 8 November 2022. Retrieved 14 September 2022. https://www.washingtonpost.com/news/retropolis/wp/2017/05/09/guinea-pigs-or-pioneers-how-puerto-rican-women-were-used-to-test-the-birth-control-pill/
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Contraceptive use by method 2019 : data booklet. [New York, NY]: United Nations. Department of Economic and Social Affairs. Population Division. 2019. ISBN 978-92-1-148329-1. OCLC 1135665739. 978-92-1-148329-1
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"Products - Data Briefs - Number 327 - December 2018". U.S. Centers for Disease Control and Prevention (CDC). 11 July 2022. Archived from the original on 13 September 2022. Retrieved 14 September 2022. https://www.cdc.gov/nchs/products/databriefs/db327.htm
Sech LA, Mishell DR (November 2015). "Oral steroid contraception". Women's Health. 11 (6): 743–748. doi:10.2217/whe.15.82. PMID 26673988. S2CID 6433771. https://doi.org/10.2217%2Fwhe.15.82
"Current Contraceptive Status Among Women Aged 15–49: United States, 2015–2017". U.S. Centers for Disease Control and Prevention (CDC). 7 June 2019. Archived from the original on 13 September 2022. Retrieved 2 August 2019. https://www.cdc.gov/nchs/products/databriefs/db327.htm
UN Population Division (2006). World Contraceptive Use 2005 (PDF). New York: United Nations. ISBN 978-92-1-151418-6. Archived (PDF) from the original on 26 April 2018. Retrieved 28 June 2017. women aged 15–49 married or in consensual union 978-92-1-151418-6
Delvin D (15 June 2016). "Contraception – the contraceptive pill: How many women take it in the UK?". Archived from the original on 4 January 2011. Retrieved 25 December 2010. http://www.netdoctor.co.uk/sex_relationships/facts/contraceptivepills.htm
Taylor T, Keyse L, Bryant A (2006). Contraception and Sexual Health, 2005/06 (PDF). London: Office for National Statistics. ISBN 978-1-85774-638-9. Archived from the original (PDF) on 9 January 2007. British women aged 16–49: 24% use the pill as of 2016[update] (17% use Combined pill, 5% use Minipill, 2% don't know type) 978-1-85774-638-9
Yoshida H, Sakamoto H, Leslie A, Takahashi O, Tsuboi S, Kitamura K (June 2016). "Contraception in Japan: Current trends". Contraception. 93 (6): 475–477. doi:10.1016/j.contraception.2016.02.006. PMID 26872717. /wiki/Doi_(identifier)
World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02. /wiki/World_Health_Organization
Harris G (3 May 2010). "The Pill Started More Than One Revolution". The New York Times. Archived from the original on 27 September 2015. Retrieved 21 September 2015. https://www.nytimes.com/2010/05/04/health/04pill.html
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
Edwards M, Can AS (2024), "Progestins", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 33085358, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK563211/
"How to Use Birth Control Pills". Planned Parenthood. Archived from the original on 6 December 2017. Retrieved 29 November 2017. https://www.plannedparenthood.org/learn/birth-control/birth-control-pill/how-do-i-use-the-birth-control-pill
"Combined hormonal contraceptives | European Medicines Agency". www.ema.europa.eu. Retrieved 28 February 2024. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/combined-hormonal-contraceptives
"Combined hormonal contraceptives | European Medicines Agency". www.ema.europa.eu. Retrieved 28 February 2024. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/combined-hormonal-contraceptives
"Combined hormonal contraceptives | European Medicines Agency". www.ema.europa.eu. Retrieved 28 February 2024. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/combined-hormonal-contraceptives
"Combined hormonal contraceptives | European Medicines Agency". www.ema.europa.eu. Retrieved 28 February 2024. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/combined-hormonal-contraceptives
"Combined hormonal contraceptives | European Medicines Agency". www.ema.europa.eu. Retrieved 28 February 2024. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/combined-hormonal-contraceptives
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
Thiyagarajan DK, Basit H, Jeanmonod R (2024), "Physiology, Menstrual Cycle", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29763196, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK500020/
"Estrogen and Progestin (Oral Contraceptives): MedlinePlus Drug Information". medlineplus.gov. Retrieved 28 February 2024. https://medlineplus.gov/druginfo/meds/a601050.html
"Estrogen and Progestin (Oral Contraceptives): MedlinePlus Drug Information". medlineplus.gov. Retrieved 28 February 2024. https://medlineplus.gov/druginfo/meds/a601050.html
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
"Estrogen and Progestin (Oral Contraceptives): MedlinePlus Drug Information". medlineplus.gov. Retrieved 28 February 2024. https://medlineplus.gov/druginfo/meds/a601050.html
Cooper DB, Patel P, Mahdy H (2024), "Oral Contraceptive Pills", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 28613632, retrieved 28 February 2024 http://www.ncbi.nlm.nih.gov/books/NBK430882/
Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M, eds. (2011). "Combined oral contraceptives (COCs)". Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 249–341. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. pp. 257–258:Mechanism of action Combined oral contraceptive pills prevent fertilization and, therefore, qualify as contraceptives. There is no significant evidence that they work after fertilization. The progestins in all combined oral contraceptives provide most of the contraceptive effect by suppressing ovulation and thickening cervical mucus, although the estrogens also make a small contribution to ovulation suppression. Cycle control is enhanced by the estrogen.Because combined oral contraceptives so effectively suppress ovulation and block ascent of sperm into the upper genital tract, the potential impact on endometrial receptivity to implantation is almost academic. When the two primary mechanisms fail, the fact that pregnancy occurs despite the endometrial changes demonstrates that those endometrial changes do not significantly contribute to the pill's mechanism of action. 978-1-59708-004-0
Speroff L, Darney PD (2011). "Oral contraception". A clinical guide for contraception (5th ed.). Philadelphia: Lippincott Williams & Wilkins. pp. 19–152. ISBN 978-1-60831-610-6. 978-1-60831-610-6
Levin ER, Hammes SR (2011). "Estrogens and progestins". In Goodman LS, Brunton LL, Chabner BA, Knollmann BC (eds.). Goodman & Gilman's pharmacological basis of therapeutics (12th ed.). New York: McGraw-Hill Medical. pp. 1163–1194. ISBN 978-0-07-162442-8. 978-0-07-162442-8
Glasier A (2010). "Contraception". In Jameson JL, De Groot LJ (eds.). Endocrinology (6th ed.). Philadelphia: Saunders Elsevier. pp. 2417–2427. ISBN 978-1-4160-5583-9. 978-1-4160-5583-9
Barbieri RL (2014), Rosenwaks Z, Wassarman PM (eds.), "The Endocrinology of the Menstrual Cycle", Human Fertility: Methods and Protocols, Methods in Molecular Biology, vol. 1154, New York, NY: Springer, pp. 145–169, doi:10.1007/978-1-4939-0659-8_7, ISBN 978-1-4939-0659-8, PMID 24782009, archived from the original on 15 July 2023, retrieved 15 September 2022 978-1-4939-0659-8
Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M, eds. (2011). "Combined oral contraceptives (COCs)". Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 249–341. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. pp. 257–258:Mechanism of action Combined oral contraceptive pills prevent fertilization and, therefore, qualify as contraceptives. There is no significant evidence that they work after fertilization. The progestins in all combined oral contraceptives provide most of the contraceptive effect by suppressing ovulation and thickening cervical mucus, although the estrogens also make a small contribution to ovulation suppression. Cycle control is enhanced by the estrogen.Because combined oral contraceptives so effectively suppress ovulation and block ascent of sperm into the upper genital tract, the potential impact on endometrial receptivity to implantation is almost academic. When the two primary mechanisms fail, the fact that pregnancy occurs despite the endometrial changes demonstrates that those endometrial changes do not significantly contribute to the pill's mechanism of action. 978-1-59708-004-0
Speroff L, Darney PD (2011). "Oral contraception". A clinical guide for contraception (5th ed.). Philadelphia: Lippincott Williams & Wilkins. pp. 19–152. ISBN 978-1-60831-610-6. 978-1-60831-610-6
Levin ER, Hammes SR (2011). "Estrogens and progestins". In Goodman LS, Brunton LL, Chabner BA, Knollmann BC (eds.). Goodman & Gilman's pharmacological basis of therapeutics (12th ed.). New York: McGraw-Hill Medical. pp. 1163–1194. ISBN 978-0-07-162442-8. 978-0-07-162442-8
Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M, eds. (2011). "Combined oral contraceptives (COCs)". Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 249–341. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. pp. 257–258:Mechanism of action Combined oral contraceptive pills prevent fertilization and, therefore, qualify as contraceptives. There is no significant evidence that they work after fertilization. The progestins in all combined oral contraceptives provide most of the contraceptive effect by suppressing ovulation and thickening cervical mucus, although the estrogens also make a small contribution to ovulation suppression. Cycle control is enhanced by the estrogen.Because combined oral contraceptives so effectively suppress ovulation and block ascent of sperm into the upper genital tract, the potential impact on endometrial receptivity to implantation is almost academic. When the two primary mechanisms fail, the fact that pregnancy occurs despite the endometrial changes demonstrates that those endometrial changes do not significantly contribute to the pill's mechanism of action. 978-1-59708-004-0
Speroff L, Darney PD (2011). "Oral contraception". A clinical guide for contraception (5th ed.). Philadelphia: Lippincott Williams & Wilkins. pp. 19–152. ISBN 978-1-60831-610-6. 978-1-60831-610-6
Levin ER, Hammes SR (2011). "Estrogens and progestins". In Goodman LS, Brunton LL, Chabner BA, Knollmann BC (eds.). Goodman & Gilman's pharmacological basis of therapeutics (12th ed.). New York: McGraw-Hill Medical. pp. 1163–1194. ISBN 978-0-07-162442-8. 978-0-07-162442-8
Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M, eds. (2011). "Combined oral contraceptives (COCs)". Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 249–341. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. pp. 257–258:Mechanism of action Combined oral contraceptive pills prevent fertilization and, therefore, qualify as contraceptives. There is no significant evidence that they work after fertilization. The progestins in all combined oral contraceptives provide most of the contraceptive effect by suppressing ovulation and thickening cervical mucus, although the estrogens also make a small contribution to ovulation suppression. Cycle control is enhanced by the estrogen.Because combined oral contraceptives so effectively suppress ovulation and block ascent of sperm into the upper genital tract, the potential impact on endometrial receptivity to implantation is almost academic. When the two primary mechanisms fail, the fact that pregnancy occurs despite the endometrial changes demonstrates that those endometrial changes do not significantly contribute to the pill's mechanism of action. 978-1-59708-004-0
Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M, eds. (2011). "Combined oral contraceptives (COCs)". Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 249–341. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. pp. 257–258:Mechanism of action Combined oral contraceptive pills prevent fertilization and, therefore, qualify as contraceptives. There is no significant evidence that they work after fertilization. The progestins in all combined oral contraceptives provide most of the contraceptive effect by suppressing ovulation and thickening cervical mucus, although the estrogens also make a small contribution to ovulation suppression. Cycle control is enhanced by the estrogen.Because combined oral contraceptives so effectively suppress ovulation and block ascent of sperm into the upper genital tract, the potential impact on endometrial receptivity to implantation is almost academic. When the two primary mechanisms fail, the fact that pregnancy occurs despite the endometrial changes demonstrates that those endometrial changes do not significantly contribute to the pill's mechanism of action. 978-1-59708-004-0
Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M, eds. (2011). "Combined oral contraceptives (COCs)". Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 249–341. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. pp. 257–258:Mechanism of action Combined oral contraceptive pills prevent fertilization and, therefore, qualify as contraceptives. There is no significant evidence that they work after fertilization. The progestins in all combined oral contraceptives provide most of the contraceptive effect by suppressing ovulation and thickening cervical mucus, although the estrogens also make a small contribution to ovulation suppression. Cycle control is enhanced by the estrogen.Because combined oral contraceptives so effectively suppress ovulation and block ascent of sperm into the upper genital tract, the potential impact on endometrial receptivity to implantation is almost academic. When the two primary mechanisms fail, the fact that pregnancy occurs despite the endometrial changes demonstrates that those endometrial changes do not significantly contribute to the pill's mechanism of action. 978-1-59708-004-0
Nelson AL, Cwiak C (2011). "Combined oral contraceptives". In Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M (eds.). Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 253–254. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734.Ten different progestins have been used in the combined oral contraceptives that have been sold in the United States. Several different classification systems for the progestins exist, but the one most commonly used system recapitulates the history of the pill in the United States by categorizing the progestins into the so-called "generations of progestins". The first three generations of progestins are derived from 19-nortestosterone. The fourth generation is drospirenone. Newer progestins are hybrids.First-generation progestins. First-generation progestins include noretynodrel, norethisterone, norethisterone acetate, and etynodiol diacetate... These compounds have the lowest potency and relatively short half-lives. The short half-life did not matter in the early, high-dose pills but as doses of progestin were decreased in the more modern pills, problems with unscheduled spotting and bleeding became more common.Second-generation progestins. To solve the problem of unscheduled bleeding and spotting, the second generation progestins (norgestrol and levonorgestrel) were designed to be significantly more potent and to have longer half-lives than norethisterone-related progestins ... The second-generation progestins have been associated with more androgen-related side-effects such as adverse effect on lipids, oily skin, acne, and facial hair growth.Third-generation progestins. Third-generation progestins (desogestrel, norgestimate and elsewhere, gestodene) were introduced to maintain the potent progestational activity of second-generation progestins, but to reduce androgeneic side effects. Reduction in androgen impacts allows a fuller expression of the pill's estrogen impacts. This has some clinical benefits... On the other hand, concern arose that the increased expression of estrogen might increase the risk of venous thromboembolism (VTE). This concern introduced a pill scare in Europe until international studies were completed and correctly interpreted.Fourth-generation progestins. Drospirenone is an analogue of spironolactone, a potassium-sparing diuretic used to treat hypertension. Drospirenone possesses anti-mineralocorticoid and anti-androgenic properties. These properties have led to new contraceptive applications, such as treatment of premenstrual dysphoric disorder and acne... In the wake of concerns around possible increased VTE risk with less androgenic third-generation formulations, those issues were anticipated with drospirenone. They were clearly answered by large international studies.Next-generation progestins. Progestins have been developed with properties that are shared with different generations of progestins. They have more profound, diverse, and discrete effects on the endometrium than prior progestins. This class would include dienogest (United States) and nomegestrol (Europe). 978-1-59708-004-0
Speroff L, Darney PD (2011). "Oral contraception". A clinical guide for contraception (5th ed.). Philadelphia: Lippincott Williams & Wilkins. p. 40. ISBN 978-1-60831-610-6. 978-1-60831-610-6
Nelson AL, Cwiak C (2011). "Combined oral contraceptives". In Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M (eds.). Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 253–254. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734.Ten different progestins have been used in the combined oral contraceptives that have been sold in the United States. Several different classification systems for the progestins exist, but the one most commonly used system recapitulates the history of the pill in the United States by categorizing the progestins into the so-called "generations of progestins". The first three generations of progestins are derived from 19-nortestosterone. The fourth generation is drospirenone. Newer progestins are hybrids.First-generation progestins. First-generation progestins include noretynodrel, norethisterone, norethisterone acetate, and etynodiol diacetate... These compounds have the lowest potency and relatively short half-lives. The short half-life did not matter in the early, high-dose pills but as doses of progestin were decreased in the more modern pills, problems with unscheduled spotting and bleeding became more common.Second-generation progestins. To solve the problem of unscheduled bleeding and spotting, the second generation progestins (norgestrol and levonorgestrel) were designed to be significantly more potent and to have longer half-lives than norethisterone-related progestins ... The second-generation progestins have been associated with more androgen-related side-effects such as adverse effect on lipids, oily skin, acne, and facial hair growth.Third-generation progestins. Third-generation progestins (desogestrel, norgestimate and elsewhere, gestodene) were introduced to maintain the potent progestational activity of second-generation progestins, but to reduce androgeneic side effects. Reduction in androgen impacts allows a fuller expression of the pill's estrogen impacts. This has some clinical benefits... On the other hand, concern arose that the increased expression of estrogen might increase the risk of venous thromboembolism (VTE). This concern introduced a pill scare in Europe until international studies were completed and correctly interpreted.Fourth-generation progestins. Drospirenone is an analogue of spironolactone, a potassium-sparing diuretic used to treat hypertension. Drospirenone possesses anti-mineralocorticoid and anti-androgenic properties. These properties have led to new contraceptive applications, such as treatment of premenstrual dysphoric disorder and acne... In the wake of concerns around possible increased VTE risk with less androgenic third-generation formulations, those issues were anticipated with drospirenone. They were clearly answered by large international studies.Next-generation progestins. Progestins have been developed with properties that are shared with different generations of progestins. They have more profound, diverse, and discrete effects on the endometrium than prior progestins. This class would include dienogest (United States) and nomegestrol (Europe). 978-1-59708-004-0
Speroff L, Darney PD (2011). "Oral contraception". A clinical guide for contraception (5th ed.). Philadelphia: Lippincott Williams & Wilkins. p. 40. ISBN 978-1-60831-610-6. 978-1-60831-610-6
Nelson AL, Cwiak C (2011). "Combined oral contraceptives". In Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M (eds.). Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 253–254. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734.Ten different progestins have been used in the combined oral contraceptives that have been sold in the United States. Several different classification systems for the progestins exist, but the one most commonly used system recapitulates the history of the pill in the United States by categorizing the progestins into the so-called "generations of progestins". The first three generations of progestins are derived from 19-nortestosterone. The fourth generation is drospirenone. Newer progestins are hybrids.First-generation progestins. First-generation progestins include noretynodrel, norethisterone, norethisterone acetate, and etynodiol diacetate... These compounds have the lowest potency and relatively short half-lives. The short half-life did not matter in the early, high-dose pills but as doses of progestin were decreased in the more modern pills, problems with unscheduled spotting and bleeding became more common.Second-generation progestins. To solve the problem of unscheduled bleeding and spotting, the second generation progestins (norgestrol and levonorgestrel) were designed to be significantly more potent and to have longer half-lives than norethisterone-related progestins ... The second-generation progestins have been associated with more androgen-related side-effects such as adverse effect on lipids, oily skin, acne, and facial hair growth.Third-generation progestins. Third-generation progestins (desogestrel, norgestimate and elsewhere, gestodene) were introduced to maintain the potent progestational activity of second-generation progestins, but to reduce androgeneic side effects. Reduction in androgen impacts allows a fuller expression of the pill's estrogen impacts. This has some clinical benefits... On the other hand, concern arose that the increased expression of estrogen might increase the risk of venous thromboembolism (VTE). This concern introduced a pill scare in Europe until international studies were completed and correctly interpreted.Fourth-generation progestins. Drospirenone is an analogue of spironolactone, a potassium-sparing diuretic used to treat hypertension. Drospirenone possesses anti-mineralocorticoid and anti-androgenic properties. These properties have led to new contraceptive applications, such as treatment of premenstrual dysphoric disorder and acne... In the wake of concerns around possible increased VTE risk with less androgenic third-generation formulations, those issues were anticipated with drospirenone. They were clearly answered by large international studies.Next-generation progestins. Progestins have been developed with properties that are shared with different generations of progestins. They have more profound, diverse, and discrete effects on the endometrium than prior progestins. This class would include dienogest (United States) and nomegestrol (Europe). 978-1-59708-004-0
Speroff L, Darney PD (2011). "Oral contraception". A clinical guide for contraception (5th ed.). Philadelphia: Lippincott Williams & Wilkins. p. 40. ISBN 978-1-60831-610-6. 978-1-60831-610-6
Speroff L, Darney PD (2011). "Oral contraception". A clinical guide for contraception (5th ed.). Philadelphia: Lippincott Williams & Wilkins. p. 40. ISBN 978-1-60831-610-6. 978-1-60831-610-6
Nelson AL, Cwiak C (2011). "Combined oral contraceptives". In Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M (eds.). Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 253–254. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734.Ten different progestins have been used in the combined oral contraceptives that have been sold in the United States. Several different classification systems for the progestins exist, but the one most commonly used system recapitulates the history of the pill in the United States by categorizing the progestins into the so-called "generations of progestins". The first three generations of progestins are derived from 19-nortestosterone. The fourth generation is drospirenone. Newer progestins are hybrids.First-generation progestins. First-generation progestins include noretynodrel, norethisterone, norethisterone acetate, and etynodiol diacetate... These compounds have the lowest potency and relatively short half-lives. The short half-life did not matter in the early, high-dose pills but as doses of progestin were decreased in the more modern pills, problems with unscheduled spotting and bleeding became more common.Second-generation progestins. To solve the problem of unscheduled bleeding and spotting, the second generation progestins (norgestrol and levonorgestrel) were designed to be significantly more potent and to have longer half-lives than norethisterone-related progestins ... The second-generation progestins have been associated with more androgen-related side-effects such as adverse effect on lipids, oily skin, acne, and facial hair growth.Third-generation progestins. Third-generation progestins (desogestrel, norgestimate and elsewhere, gestodene) were introduced to maintain the potent progestational activity of second-generation progestins, but to reduce androgeneic side effects. Reduction in androgen impacts allows a fuller expression of the pill's estrogen impacts. This has some clinical benefits... On the other hand, concern arose that the increased expression of estrogen might increase the risk of venous thromboembolism (VTE). This concern introduced a pill scare in Europe until international studies were completed and correctly interpreted.Fourth-generation progestins. Drospirenone is an analogue of spironolactone, a potassium-sparing diuretic used to treat hypertension. Drospirenone possesses anti-mineralocorticoid and anti-androgenic properties. These properties have led to new contraceptive applications, such as treatment of premenstrual dysphoric disorder and acne... In the wake of concerns around possible increased VTE risk with less androgenic third-generation formulations, those issues were anticipated with drospirenone. They were clearly answered by large international studies.Next-generation progestins. Progestins have been developed with properties that are shared with different generations of progestins. They have more profound, diverse, and discrete effects on the endometrium than prior progestins. This class would include dienogest (United States) and nomegestrol (Europe). 978-1-59708-004-0
Nelson AL, Cwiak C (2011). "Combined oral contraceptives". In Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M (eds.). Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 253–254. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734.Ten different progestins have been used in the combined oral contraceptives that have been sold in the United States. Several different classification systems for the progestins exist, but the one most commonly used system recapitulates the history of the pill in the United States by categorizing the progestins into the so-called "generations of progestins". The first three generations of progestins are derived from 19-nortestosterone. The fourth generation is drospirenone. Newer progestins are hybrids.First-generation progestins. First-generation progestins include noretynodrel, norethisterone, norethisterone acetate, and etynodiol diacetate... These compounds have the lowest potency and relatively short half-lives. The short half-life did not matter in the early, high-dose pills but as doses of progestin were decreased in the more modern pills, problems with unscheduled spotting and bleeding became more common.Second-generation progestins. To solve the problem of unscheduled bleeding and spotting, the second generation progestins (norgestrol and levonorgestrel) were designed to be significantly more potent and to have longer half-lives than norethisterone-related progestins ... The second-generation progestins have been associated with more androgen-related side-effects such as adverse effect on lipids, oily skin, acne, and facial hair growth.Third-generation progestins. Third-generation progestins (desogestrel, norgestimate and elsewhere, gestodene) were introduced to maintain the potent progestational activity of second-generation progestins, but to reduce androgeneic side effects. Reduction in androgen impacts allows a fuller expression of the pill's estrogen impacts. This has some clinical benefits... On the other hand, concern arose that the increased expression of estrogen might increase the risk of venous thromboembolism (VTE). This concern introduced a pill scare in Europe until international studies were completed and correctly interpreted.Fourth-generation progestins. Drospirenone is an analogue of spironolactone, a potassium-sparing diuretic used to treat hypertension. Drospirenone possesses anti-mineralocorticoid and anti-androgenic properties. These properties have led to new contraceptive applications, such as treatment of premenstrual dysphoric disorder and acne... In the wake of concerns around possible increased VTE risk with less androgenic third-generation formulations, those issues were anticipated with drospirenone. They were clearly answered by large international studies.Next-generation progestins. Progestins have been developed with properties that are shared with different generations of progestins. They have more profound, diverse, and discrete effects on the endometrium than prior progestins. This class would include dienogest (United States) and nomegestrol (Europe). 978-1-59708-004-0
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The effects of broad-spectrum antibiotics on Combined contraceptive pills is not found on systematic interaction metanalysis (Archer, 2002), although "individual patients do show large decreases in the plasma concentrations of ethinylestradiol when they take certain other antibiotics" (Dickinson, 2001). "experts on this topic still recommend informing oral contraceptive users of the potential for a rare interaction" (DeRossi, 2002) and this remains current (2006) UK Family Planning Association advice Archived 8 February 2007 at the Wayback Machine. http://www.fpa.org.uk/information/leaflets/documents_and_pdfs/detail.cfm?contentID=130#17
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Pincus G, Bialy G (1964). Drugs Used in Control of Reproduction. Advances in Pharmacology. Vol. 3. Academic Press. pp. 285–313. doi:10.1016/S1054-3589(08)61115-1. ISBN 978-0-12-032903-8. PMID 14232795. The original observation of Makepeace et al. (1937) that progesterone inhibited ovulation in the rabbit was substantiated by Pincus and Chang (1953). In women, 300 mg of progesterone per day taken orally resulted in ovulation inhibition in 80% of cases (Pincus, 1956). The high dosage and frequent incidence of breakthrough bleeding limited the practical application of the method. Subsequently, the utilization of potent 19-norsteroids, which could be given orally, opened the field to practical oral contraception. 978-0-12-032903-8
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Reed J (1978). From Private Vice to Public Virtue: The Birth Control Movement and American Society Since 1830. New York: Basic Books. ISBN 978-0-465-02582-4. 978-0-465-02582-4
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Pincus G (December 1958). "The hormonal control of ovulation and early development". Postgraduate Medicine. 24 (6): 654–60. doi:10.1080/00325481.1958.11692305. PMID 13614060. /wiki/Doi_(identifier)
Pincus G (December 1958). "The hormonal control of ovulation and early development". Postgraduate Medicine. 24 (6): 654–60. doi:10.1080/00325481.1958.11692305. PMID 13614060. /wiki/Doi_(identifier)
Pincus G (December 1958). "The hormonal control of ovulation and early development". Postgraduate Medicine. 24 (6): 654–60. doi:10.1080/00325481.1958.11692305. PMID 13614060. /wiki/Doi_(identifier)
Pincus G (1959). Progestational Agents and the Control of Fertility. Vitamins & Hormones. Vol. 17. Academic Press. pp. 307–324. doi:10.1016/S0083-6729(08)60274-5. ISBN 978-0-12-709817-3. ISSN 0083-6729. Ishikawa et al. (1957) employing the same regime of progesterone administration also observed suppression of ovulation in a proportion of the cases taken to laparotomy. Although sexual intercourse was practised freely by the subjects of our experiments and those of Ishikawa el al., no pregnancies occurred. Since ovulation presumably took place in a proportion of cycles, the lack of any pregnancies may be due to chance, but Ishikawa et al. (1957) have presented data indicating that in women receiving oral progesterone the cervical mucus becomes impenetrable to sperm. 978-0-12-709817-3
Pincus G (1959). Progestational Agents and the Control of Fertility. Vitamins & Hormones. Vol. 17. Academic Press. pp. 307–324. doi:10.1016/S0083-6729(08)60274-5. ISBN 978-0-12-709817-3. ISSN 0083-6729. Ishikawa et al. (1957) employing the same regime of progesterone administration also observed suppression of ovulation in a proportion of the cases taken to laparotomy. Although sexual intercourse was practised freely by the subjects of our experiments and those of Ishikawa el al., no pregnancies occurred. Since ovulation presumably took place in a proportion of cycles, the lack of any pregnancies may be due to chance, but Ishikawa et al. (1957) have presented data indicating that in women receiving oral progesterone the cervical mucus becomes impenetrable to sperm. 978-0-12-709817-3
Diczfalusy E (December 1965). "Probable mode of action of oral contraceptives". BMJ. 2 (5475): 1394–9. doi:10.1136/bmj.2.5475.1394. PMC 1847181. PMID 5848673. At the Fifth International Conference on Planned Parenthood in Tokyo, Pincus (1955) reported an ovulation inhibition by progesterone or norethynodrel1 taken orally by women. This report indicated the beginning of a new era in the history of contraception. ... That the cervical mucus might be one of the principal sites of action was suggested by the first studies of Pincus (1956, 1959) and of Ishikawa et al. (1957). These investigators found that no pregnancies occurred in women treated orally with large doses of progesterone, though ovulation was inhibited only in some 70% of the cases studied. ... The mechanism of protection in this method—and probably in that of Pincus (1956) and of Ishikawa et al. (1957)—must involve an effect on the cervical mucus and/or endometrium and Fallopian tubes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1847181
Pincus G (1959). Progestational Agents and the Control of Fertility. Vitamins & Hormones. Vol. 17. Academic Press. pp. 307–324. doi:10.1016/S0083-6729(08)60274-5. ISBN 978-0-12-709817-3. ISSN 0083-6729. Ishikawa et al. (1957) employing the same regime of progesterone administration also observed suppression of ovulation in a proportion of the cases taken to laparotomy. Although sexual intercourse was practised freely by the subjects of our experiments and those of Ishikawa el al., no pregnancies occurred. Since ovulation presumably took place in a proportion of cycles, the lack of any pregnancies may be due to chance, but Ishikawa et al. (1957) have presented data indicating that in women receiving oral progesterone the cervical mucus becomes impenetrable to sperm. 978-0-12-709817-3
Diczfalusy E (December 1965). "Probable mode of action of oral contraceptives". BMJ. 2 (5475): 1394–9. doi:10.1136/bmj.2.5475.1394. PMC 1847181. PMID 5848673. At the Fifth International Conference on Planned Parenthood in Tokyo, Pincus (1955) reported an ovulation inhibition by progesterone or norethynodrel1 taken orally by women. This report indicated the beginning of a new era in the history of contraception. ... That the cervical mucus might be one of the principal sites of action was suggested by the first studies of Pincus (1956, 1959) and of Ishikawa et al. (1957). These investigators found that no pregnancies occurred in women treated orally with large doses of progesterone, though ovulation was inhibited only in some 70% of the cases studied. ... The mechanism of protection in this method—and probably in that of Pincus (1956) and of Ishikawa et al. (1957)—must involve an effect on the cervical mucus and/or endometrium and Fallopian tubes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1847181
Pincus G, Bialy G (1964). Drugs Used in Control of Reproduction. Advances in Pharmacology. Vol. 3. Academic Press. pp. 285–313. doi:10.1016/S1054-3589(08)61115-1. ISBN 978-0-12-032903-8. PMID 14232795. The original observation of Makepeace et al. (1937) that progesterone inhibited ovulation in the rabbit was substantiated by Pincus and Chang (1953). In women, 300 mg of progesterone per day taken orally resulted in ovulation inhibition in 80% of cases (Pincus, 1956). The high dosage and frequent incidence of breakthrough bleeding limited the practical application of the method. Subsequently, the utilization of potent 19-norsteroids, which could be given orally, opened the field to practical oral contraception. 978-0-12-032903-8
Ramírez de Arellano AB, Seipp C (10 October 2017). Colonialism, Catholicism, and Contraception: A History of Birth Control in Puerto Rico. University of North Carolina Press. pp. 107–. ISBN 978-1-4696-4001-3. Archived from the original on 15 July 2023. Retrieved 2 May 2019. Still, neither of the two researchers was completely satisfied with the results. Progesterone tended to cause "premature menses", or breakthrough bleeding, in approximately 20 percent of the cycles, an occurrence that disturbed the patients and worried Rock.17 In addition, Pincus was concerned about the failure to inhibit ovulation in all the cases. Only large doses of orally administered progesterone could insure the suppression of ovulation, and these doses were expensive. The mass use of this regimen as a birth control method was thus seriously imperiled. 978-1-4696-4001-3
Pincus G, Bialy G (1964). Drugs Used in Control of Reproduction. Advances in Pharmacology. Vol. 3. Academic Press. pp. 285–313. doi:10.1016/S1054-3589(08)61115-1. ISBN 978-0-12-032903-8. PMID 14232795. The original observation of Makepeace et al. (1937) that progesterone inhibited ovulation in the rabbit was substantiated by Pincus and Chang (1953). In women, 300 mg of progesterone per day taken orally resulted in ovulation inhibition in 80% of cases (Pincus, 1956). The high dosage and frequent incidence of breakthrough bleeding limited the practical application of the method. Subsequently, the utilization of potent 19-norsteroids, which could be given orally, opened the field to practical oral contraception. 978-0-12-032903-8
Ramírez de Arellano AB, Seipp C (10 October 2017). Colonialism, Catholicism, and Contraception: A History of Birth Control in Puerto Rico. University of North Carolina Press. pp. 107–. ISBN 978-1-4696-4001-3. Archived from the original on 15 July 2023. Retrieved 2 May 2019. Still, neither of the two researchers was completely satisfied with the results. Progesterone tended to cause "premature menses", or breakthrough bleeding, in approximately 20 percent of the cycles, an occurrence that disturbed the patients and worried Rock.17 In addition, Pincus was concerned about the failure to inhibit ovulation in all the cases. Only large doses of orally administered progesterone could insure the suppression of ovulation, and these doses were expensive. The mass use of this regimen as a birth control method was thus seriously imperiled. 978-1-4696-4001-3
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