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Combined injectable birth control

Combined injectable contraceptives (CICs) are a form of hormonal birth control for women. They consist of monthly injections of combined formulations containing an estrogen and a progestin to prevent pregnancy.

CICs are different from progestogen-only injectable contraceptives (POICs), such as depot medroxyprogesterone acetate (DMPA; brand names Depo-Provera, Depo-SubQ Provera 104) and norethisterone enantate (NETE; brand name Noristerat), which are not combined with an estrogen and are given once every two to three months instead of once a month.

Hormonal contraception works primarily by preventing ovulation, but it may also thicken the cervical mucus inhibiting sperm penetration. Hormonal contraceptives also have effects on the endometrium, that theoretically could affect implantation.

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Medical uses

CICs are administered by intramuscular injection into the deltoid, gluteus maximus, or anterior thigh.11 They are ideally administered every 28 to 30 days, though they have been demonstrated to be effective up to 33 days.12

Some CICs have been said to be used by transgender women as a means of feminizing hormone therapy as well.13

Available forms

Combined injectable contraceptives marketed for clinical use
CompositionDoseVehicleBrand NamesAvailability
Estradiol valerate / Norethisterone enantate5 mg /50 mgOil solutionMultiple14Approved in at least 36 countries
Estradiol cypionate / Medroxyprogesterone acetate5 mg /25 mgMicrocrystalline aqueous suspensionMultiple15Approved in at least 18 countries
Estradiol enantate / Algestone acetophenidea10 mg /150 mgOil solutionMultiple16Approved in at least 19 countries
5 mg /75 mgOil solutionAnafertin†, Patector NF, YectamesApproved at least 9 countries
10 mg /120 mgOil solutionUnalmes, YectunaApproved in at least 3 countries
10 mg /75 mgOil solutionOva Repos†Discontinued (firm was in Spain)
Estradiol benzoate butyrate / Algestone acetophenide10 mg /150 mgOil solution?Redimen, Soluna, Unijab, Unimens§Approved in Peru and Singapore
Estradiol valerate / Hydroxyprogesterone caproate5 mg /250 mgOil solutionChinese Injectable No. 1Approved in China
Estradiol / Megestrol acetate3.5 mg /25 mgMicrocrystalline aqueous suspensionChinese Injectable No. 2, Mego-EApproved in China
Estradiol cypionate / Hydroxyprogesterone caproate5 mg /250 mgOil solution?Sinbios†Discontinued (firm was in Mexico)
Estradiol valerate / Estradiol benzoate / Hydroxyprogesterone caproate10 mg /1 mg /250 mgOil solution?Sin-Ol†Discontinued (firm was in Mexico)
Notes: All are given by intramuscular injection once a month. Footnotes: † = Discontinued. § = Never marketed. a = Unsorted brand names (doses unknown; for E2-EN/DHPATooltip estradiol enantate/algestone acetophenide): Evitas† and Femineo†. Sources: 171819202122232425262728

A variety of different CICs, generally containing a short-acting natural estradiol ester and a long-acting progestin ester, are available for clinical use.2930313233 Estrogens that are used include estradiol valerate, estradiol cypionate, estradiol enantate, estradiol benzoate butyrate, and estradiol, while progestins that are used include norethisterone enantate, medroxyprogesterone acetate, algestone acetophenide (dihydroxyprogesterone acetophenide), hydroxyprogesterone caproate, and megestrol acetate.34353637 Estradiol benzoate has a duration that is too short for once-monthly CICs, and is not used in them.38 Conversely, estradiol enantate is said to have a duration that is too long for once-monthly CICs, but is nonetheless used in them.39

Side effects

Side effects of CICs, besides menstrual bleeding changes, are minimal.40 The most prominent side effects of CICs are menstrual irregularities during the first 3 to 6 months of use.41 Dysmenorrhea has been reported in 30 to 65% of women.42 Other side effects include breast tenderness/pain, headache, and libido changes.43 Some fluid retention can occur, but weight gain is minimal.44 Local injection site reactions have also been reported in 15 to 35% of women.45

Effects of CICs on coagulation and fibrinolysis are minimal and are not thought to be clinically relevant.46 Conversely, combined oral contraceptive pills containing ethinylestradiol have considerable effects on coagulation and fibrinolysis.47 The differences can be attributed to the lack of the first-pass effect with parenteral administration as well as structural and pharmacological differences between estradiol and ethinylestradiol.4849

Pharmacology

CICs contain an estrogen and a progestin. The estrogen is generally a short-acting estradiol ester, which acts as a prodrug of estradiol.50 Esters of estradiol are natural and bioidentical estrogens, and are believed to have more favorable effects on lipid metabolism, cardiovascular health, and hemostasis than synthetic estrogens such as ethinylestradiol.515253 The progestin is a long-acting progestogen ester, which may or may not act as a prodrug.54 Progesterone derivatives including medroxyprogesterone acetate, algestone acetophenide (dihydroxyprogesterone acetophenide), hydroxyprogesterone caproate, and megestrol acetate are active themselves and are not prodrugs, whereas the testosterone derivative norethisterone enantate is a prodrug of norethisterone. Regardless of whether they are prodrugs or not, steroid esters form a depot and have an extended duration of action due to a depot effect when administered by intramuscular or subcutaneous injection.

Because CICs are administered parenterally, they bypass the first-pass effect in the liver and intestines that occurs with oral administration of estrogens.55 However, is estimated that about 20% of an administered dose does still eventually pass through the liver.56 Hence, these preparations are not completely liver-neutral.57 Nonetheless, they have dramatically reduced hepatic effects relative to oral ethinylestradiol.58 In addition, parenteral estradiol in general has about 4- or 5-fold reduced potency in the liver than oral estradiol.59

CICs have antigonadotropic effects via their estrogenic and progestogenic activity and inhibit fertility and suppress sex hormone levels. A single intramuscular injection of estradiol valerate/norethisterone enanthate (5 mg/50 mg) (Mesigyna) has been found to strongly suppress testosterone levels in men.60 Testosterone levels decreased from a baseline of ~503 ng/dL to a trough of ~30 ng/dL (a 94% decrease) which occurred at day 7 post-injection.61

Estradiol levels with combined injectable contraceptives62
PreparationFormDoseEstradiol CmaxEstradiol Tmax
EV/NETEOil solution5 mg/50 mg232–428 pg/mL2 days
EC/MPAAqueous suspension5 mg/25 mg184–736 pg/mL2–4 days
EEn/DHPAOil solution10 mg/150 mg314–317 pg/mL4.2–8.1 days
5 mg/75 mg148 pg/mL6.5 days
  • v
  • t
  • e
Potencies and durations of natural estrogens by intramuscular injection
EstrogenFormDose (mg)Duration by dose (mg)
EPDCICD
EstradiolAq. soln.?–<1 d
Oil soln.40–60–1–2 ≈ 1–2 d
Aq. susp.?3.50.5–2 ≈ 2–7 d; 3.5 ≈ >5 d
Microsph.?–1 ≈ 30 d
Estradiol benzoateOil soln.25–35–1.66 ≈ 2–3 d; 5 ≈ 3–6 d
Aq. susp.20–10 ≈ 16–21 d
Emulsion?–10 ≈ 14–21 d
Estradiol dipropionateOil soln.25–30–5 ≈ 5–8 d
Estradiol valerateOil soln.20–3055 ≈ 7–8 d; 10 ≈ 10–14 d;40 ≈ 14–21 d; 100 ≈ 21–28 d
Estradiol benz. butyrateOil soln.?1010 ≈ 21 d
Estradiol cypionateOil soln.20–30–5 ≈ 11–14 d
Aq. susp.?55 ≈ 14–24 d
Estradiol enanthateOil soln.?5–1010 ≈ 20–30 d
Estradiol dienanthateOil soln.?–7.5 ≈ >40 d
Estradiol undecylateOil soln.?–10–20 ≈ 40–60 d;25–50 ≈ 60–120 d
Polyestradiol phosphateAq. soln.40–60–40 ≈ 30 d; 80 ≈ 60 d;160 ≈ 120 d
EstroneOil soln.?–1–2 ≈ 2–3 d
Aq. susp.?–0.1–2 ≈ 2–7 d
EstriolOil soln.?–1–2 ≈ 1–4 d
Polyestriol phosphateAq. soln.?–50 ≈ 30 d; 80 ≈ 60 d
  • v
  • t
  • e
Parenteral potencies and durations of progestogens6364
CompoundFormDose for specific uses (mg)65DOA66
TFD67POICD68CICD69
Algestone acetophenideOil soln.––75–15014–32 d
Gestonorone caproateOil soln.25–50––8–13 d
Hydroxyprogest. acetate70Aq. susp.350––9–16 d
Hydroxyprogest. caproateOil soln.250–50071–250–5005–21 d
Medroxyprog. acetateAq. susp.50–1001502514–50+ d
Megestrol acetateAq. susp.––25>14 d
Norethisterone enanthateOil soln.100–2002005011–52 d
ProgesteroneOil soln.20072––2–6 d
Aq. soln.?––1–2 d
Aq. susp.50–200––7–14 d

History

The first CIC to be studied was estradiol valerate/hydroxyprogesterone caproate (EV/OHPC) in 1963, and the second CIC to be studied was estradiol enantate/algestone acetophenide (E2-EN/DHPA) in 1964.7374 In 1967, E2-EN/DHPA was in the late stages of clinical development.7576 By 1969, the medication was available for medical use under the brand name Perlutal.77 Within a few years, it was marketed under other brand names such as Topasel and Ova-Repos as well.78798081 In addition, several other CICs had been introduced for medical use by 1972.82 By 1976, two major CICs were in use: E2-EN/DHPA (brand names Perlutan, Topasel) in Spain and Latin America, and EV/OHPC (brand name Injectable No. 1) in China.83 These CICs have been described as first-generation CICs.84 Two second-generation CICs, estradiol cypionate/medroxyprogesterone acetate (EC/MPA; brand names Cyclofem and later Lunelle) and estradiol valerate/norethisterone enantate (EV/NETE; brand name Mesigyna), were introduced for clinical use in 1993.858687 On 5 October 2000, Pharmacia received FDA approval for Lunelle Monthly Contraceptive Injection.88 In April 2003, Pharmacia was acquired by Pfizer (makers of depot medroxyprogesterone acetate). In October 2003, Lunelle was discontinued in the United States.

Society and culture

Availability

CICs are available in many countries throughout the world, including widely throughout Central and South America, in Mexico and the Caribbean, in China, in several Southeast Asian and African countries, and in Turkey.899091929394959697 They were also previously available in the United States, Portugal, and Spain, but have been discontinued in these countries.9899

Research

Many other CICs have been studied but have not been approved or marketed for clinical use.100101102103104105

The following are marketed CICs at different doses than those that are approved:

The half-progestin-dose formulation of estradiol valerate/norethisterone enantate (5 mg / 25 mg) is also known as HRP-103 and the half-progestin-dose formulation of estradiol cypionate/medroxyprogesterone acetate (5 mg / 12.5 mg) is also known as HRP-113.113

The following are CICs that have never been marketed:

See also

Further reading

References

  1. Bagade O, Pawar V, Patel R, Patel B, Awasarkar V, Diwate S (2014). "Increasing use of long-acting reversible contraception: safe, reliable, and cost-effective birth control" (PDF). World J Pharm Pharm Sci. 3 (10): 364–392. ISSN 2278-4357. Archived from the original (PDF) on 2017-08-10. Retrieved 2016-08-24. https://web.archive.org/web/20170810000242/http://www.wjpps.com/download/article/1412071798.pdf ↩

  2. Tamara Callahan MD , Aaron Caughey MD , Blueprints Obstetrics and Gynecology, 2013 ↩

  3. KD Tripathi , Essentials of Medical Pharmacology, 2013 ↩

  4. Dc Dutta's Textbook of Obstetrics, 2014 ↩

  5. K. A. Petrie, A. H. Torgal, C. L. Westhoff, Matched-pairs analysis of ovarian suppressionduring oral vs. vaginal hormonal contraceptive use, „Contraception” 2011, t. 84, p. e2-3 ↩

  6. R. L. Birtch, O. A. Olatunbosum, R. A. Pierson, Ovarian follicular dynamics during conventional vs continuous oral contraceptive use, „Contraception” 2006, t. 73, p. 235. p. 239. ↩

  7. K. Bugge, K. S. Richter, J. Bromer, et al., Pregnancy rates following in vitro fertilization are reduced with a thin endometrium, but are unrelated to endometrial thickness above 10 millimeters,„Fertility and Sterility” 2004, t. 82, p. S199. ↩

  8. T. Fiumino, A. Kuwata, A. Teranischi et al., Significance of endometrium thickness to evaluate endometrial receptivity for embryos in natural cycle, „Fertility and Sterility” 2008, t. 90,p. S159. ↩

  9. K. S. Richter, K. R. Bugge, J. G. Bromer, Relationship between endometrial thickness and embryo implantation, based on 1. 294 cycles of in vitro fertilization with transfer of two blastocyst-stage embryos, „Fertility and Sterility” 2007, t. 87, p. 53. ↩

  10. Rivera R, Yacobson I, Grimes D (1999). "The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices". Am J Obstet Gynecol. 181 (5 Pt 1): 1263–9. doi:10.1016/S0002-9378(99)70120-1. PMID 10561657. /wiki/Doi_(identifier) ↩

  11. "FDA Approves Combined Monthly Injectable Contraceptive". Contraception Report. 12 (3). 2001. Archived from the original on September 26, 2006. https://web.archive.org/web/20060926040811/http://www.contraceptiononline.org/contrareport/article01.cfm?art=176 ↩

  12. "FDA Approves Combined Monthly Injectable Contraceptive". Contraception Report. 12 (3). 2001. Archived from the original on September 26, 2006. https://web.archive.org/web/20060926040811/http://www.contraceptiononline.org/contrareport/article01.cfm?art=176 ↩

  13. Don Kulick (12 January 2009). Travesti: Sex, Gender, and Culture among Brazilian Transgendered Prostitutes. University of Chicago Press. pp. 64–66. ISBN 978-0-226-46101-4. 978-0-226-46101-4 ↩

  14. Chinese Injectable No. 3, Efectimes, Ginediol, Mesigyna, Mesilar, Meslart, Mesocept, Mesygest, Nofertyl, Nofertyl Lafrancol, Noregyna, Norestrin, Norifam, Norigynon, Nostidyn, Sexseg, Solouna ↩

  15. Ciclofem, Ciclofemina, Cyclofem, Cyclofemina, Cyclogeston, Femelin, Femydrol, Gestin, Harmonis, Lunella, Lunelle†, Novafem ↩

  16. Acefil, Agurin†, Atrimon†, Ciclomes, Ciclovar, Ciclovular, Cicnor†, Clinomin, Cycloven, Daiva, Damix, Deladroxate§, Deprans, Deproxone, Exuna, Ginestest, Ginoplan†, Gynomes, Horprotal, Listen, Luvonal, Neogestar, Neolutin, Nomagest, Nonestrol, Normagest, Normensil, Novular, Oterol, Ovoginal, Patector, Patectro, Perludil, Perlumes, Perlutal, Perlutale, Perlutan, Perlutin, Perlutin-Unifarma, Permisil, Preg-Less, Pregnolan, Primyfar†, Progestrol†, Protegin, Proter, Seguralmes, Synovular, Topasel, Unigalen, Uno-Ciclo, Vagital ↩

  17. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans; International Agency for Research on Cancer (1 January 1999). Hormonal Contraception and Post-menopausal Hormonal Therapy (PDF). IARC. p. 65. ISBN 978-92-832-1272-0. Archived from the original (PDF) on 28 August 2021. Retrieved 18 September 2018. 978-92-832-1272-0 ↩

  18. Bagade O, Pawar V, Patel R, Patel B, Awasarkar V, Diwate S (2014). "Increasing use of long-acting reversible contraception: safe, reliable, and cost-effective birth control" (PDF). World J Pharm Pharm Sci. 3 (10): 364–392. ISSN 2278-4357. Archived from the original (PDF) on 2017-08-10. Retrieved 2016-08-24. https://web.archive.org/web/20170810000242/http://www.wjpps.com/download/article/1412071798.pdf ↩

  19. Pramilla Senanayake; Malcolm Potts (14 April 2008). Atlas of Contraception, Second Edition. CRC Press. pp. 50–. ISBN 978-0-203-34732-4. 978-0-203-34732-4 ↩

  20. Newton JR, D'arcangues C, Hall PE (1994). "A review of "once-a-month" combined injectable contraceptives". J Obstet Gynaecol (Lahore). 4 Suppl 1: S1–34. doi:10.3109/01443619409027641. PMID 12290848. /wiki/Doi_(identifier) ↩

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  22. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans; World Health Organization; International Agency for Research on Cancer (2007). Combined Estrogen-progestogen Contraceptives and Combined Estrogen-progestogen Menopausal Therapy. World Health Organization. pp. 431–. ISBN 978-92-832-1291-1. 978-92-832-1291-1 ↩

  23. Klitsch M (1995). "Still waiting for the contraceptive revolution". Fam Plann Perspect. 27 (6): 246–53. doi:10.2307/2136177. JSTOR 2136177. PMID 8666089. /wiki/Doi_(identifier) ↩

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  25. Harry W. Rudel; Fred A. Kinel (September 1972). "Oral Contraceptives. Human Fertility Studies and Side Effects". In M. Tausk (ed.). Pharmacology of the Endocrine System and Related Drugs: Progesterone, Progestational Drugs and Antifertility Agents. Vol. II. Pergamon Press. pp. 385–469. ISBN 978-0080168128. OCLC 278011135. 978-0080168128 ↩

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  63. Sources: [34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52] ↩

  64. All given by intramuscular or subcutaneous injection. /wiki/Intramuscular_injection ↩

  65. Progesterone production during the luteal phase is ~25 (15–50) mg/day. The OIDTooltip ovulation-inhibiting dose of OHPC is 250 to 500 mg/month. /wiki/Luteal_phase ↩

  66. Duration of action in days. ↩

  67. Usually given for 14 days. ↩

  68. Usually dosed every two to three months. ↩

  69. Usually dosed once monthly. ↩

  70. Never marketed or approved by this route. ↩

  71. In divided doses (2 × 125 or 250 mg for OHPC, 10 × 20 mg for P4). ↩

  72. In divided doses (2 × 125 or 250 mg for OHPC, 10 × 20 mg for P4). ↩

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  77. Hispano americano. Tiempo. May 1969. p. 46. Entre los anovulatorios más usados están los siguientes: Prolestrín, Sequens, Anovlar, Sequentex, Orlex, Ginovlar, Enginón, Perlutal, Depo-proveda, Aconcén, Ovral, Retex, Lorophyn y otros menos solicitados. https://books.google.com/books?id=xpQYAQAAIAAJ ↩

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