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One Male Condom
open-in-new
<h2 id="variations">Variations</h2> <p>Three basic versions of the One brand condom are produced, called standard, thin and fitted.<a class="footnote-ref" id="fnref:9" href="#fn:9"><sup>9</sup></a> The fitted condoms are available in more than 50 different sizes, and a paper template is provided to assist with identifying the best fitted size for each user, selecting among 10 lengths and 9 widths.<a class="footnote-ref" id="fnref:10" href="#fn:10"><sup>10</sup></a><a class="footnote-ref" id="fnref:11" href="#fn:11"><sup>11</sup></a> </p> <h2 id="efficacy">Efficacy</h2> <p>The study of efficacy included evaluation of condom failures, discomfort, STIs, and <a href="/facts/Urinary_tract_infection/4NwY9tL0">urinary tract infections</a> (UTIs). The results were described in an FDA press release, saying: </p> <blockquote><p>The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. All participants were between 18 through 54 years old. The study found that the total condom failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse with the One Male Condom. Condom failure rate was defined as the number of slippage, breakage or both slippage and breakage events that occurred over the total number of sex acts performed. For the One Male Condom, the overall percentage of adverse events was 1.92%. Adverse events reported during the clinical trial included symptomatic STI or recent STI diagnosis (0.64%), condom or lubricant-related discomfort (0.85%), partner discomfort with lubricant (0.21%) and partner urinary tract infection (0.21%). The symptomatic STI or recent STI diagnoses observed in the study were self-reported and may be the result of subjects having intercourse without a condom or may have preceded use of the One Male Condom, as STIs were not measured at baseline.</p>— <a href="/facts/U.S._Food_and_Drug_Administration/rCEnh9WB">U.S. Food and Drug Administration</a><a class="footnote-ref" id="fnref:12" href="#fn:12"><sup>12</sup></a></blockquote> <p>Trial participants were specifically instructed to use a <a href="/facts/Water-soluble_lubricant/2gdLFz5a">water-soluble lubricant</a> with each act of anal intercourse – an instruction that was not given for acts of vaginal intercourse.<a class="footnote-ref" id="fnref:13" href="#fn:13"><sup>13</sup></a> When used with an appropriate lubricant, a lower failure rate is expected for latex condoms like the One Male Condom than for <a href="/facts/Polyurethane_condom/A39P32AV">polyurethane condoms</a>, and the failure rates are not expected to differ between acts of anal versus vaginal intercourse.<a class="footnote-ref" id="fnref:14" href="#fn:14"><sup>14</sup></a> </p> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>"FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse". U.S. Food and Drug Administration. February 23, 2022. Retrieved February 20, 2023. <a href="https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse" target="_blank">https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>"FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse". U.S. Food and Drug Administration. February 23, 2022. Retrieved February 20, 2023. <a href="https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse" target="_blank">https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>Dress, Brad (February 25, 2022). "FDA approves first condom meant for anal sex". The Hill. Washington, DC. Retrieved February 25, 2022. <a href="https://thehill.com/policy/healthcare/595847-fda-approves-first-condom-meant-for-anal-sex" target="_blank">https://thehill.com/policy/healthcare/595847-fda-approves-first-condom-meant-for-anal-sex</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>Nguyen, Brian T.; Nelson, Anita L. (December 2019). "Time for the US Food and Drug Administration approval of condoms for anal intercourse". eClinicalMedicine. 17: 100226. doi:10.1016/j.eclinm.2019.11.019. PMC 6933260. PMID 31891150. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933260" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933260</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>"FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse". U.S. Food and Drug Administration. February 23, 2022. Retrieved February 20, 2023. <a href="https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse" target="_blank">https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> <li id="fn:6"><p>"ONE Condoms are first to receive FDA approval for anal sex!". One condoms (Press release). February 23, 2023. <a href="https://www.onecondoms.com/blogs/press-releases/one-brand-condoms-are-first-to-receive-fda-approval-for-safe-and-effective-use-for-anal-sex" target="_blank">https://www.onecondoms.com/blogs/press-releases/one-brand-condoms-are-first-to-receive-fda-approval-for-safe-and-effective-use-for-anal-sex</a> <a href="#fnref:6" class="footnote-back-ref">↩</a></p></li> <li id="fn:7"><p>"Karex to buy remaining 30% stake in US condom firm GP". The Edge Markets. November 12, 2020. Retrieved 2021-06-28. <a href="http://www.theedgemarkets.com/article/karex-buy-remaining-30-stake-us-condom-firm-gp" target="_blank">http://www.theedgemarkets.com/article/karex-buy-remaining-30-stake-us-condom-firm-gp</a> <a href="#fnref:7" class="footnote-back-ref">↩</a></p></li> <li id="fn:8"><p>"Global condom shortage looms as coronavirus shuts down production". The Guardian. March 27, 2020. Archived from the original on 8 April 2020. <a href="https://web.archive.org/web/20200408162116/https://www.theguardian.com/world/2020/mar/27/global-condom-shortage-coronavirus-shuts-down-production" target="_blank">https://web.archive.org/web/20200408162116/https://www.theguardian.com/world/2020/mar/27/global-condom-shortage-coronavirus-shuts-down-production</a> <a href="#fnref:8" class="footnote-back-ref">↩</a></p></li> <li id="fn:9"><p>"FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse". U.S. Food and Drug Administration. February 23, 2022. Retrieved February 20, 2023. <a href="https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse" target="_blank">https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse</a> <a href="#fnref:9" class="footnote-back-ref">↩</a></p></li> <li id="fn:10"><p>"FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse". U.S. Food and Drug Administration. February 23, 2022. Retrieved February 20, 2023. <a href="https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse" target="_blank">https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse</a> <a href="#fnref:10" class="footnote-back-ref">↩</a></p></li> <li id="fn:11"><p>"Made for one very specific penis. Yours". MyONE condoms. Retrieved August 5, 2023. <a href="https://www.myonecondoms.com/" target="_blank">https://www.myonecondoms.com/</a> <a href="#fnref:11" class="footnote-back-ref">↩</a></p></li> <li id="fn:12"><p>"FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse". U.S. Food and Drug Administration. February 23, 2022. Retrieved February 20, 2023. <a href="https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse" target="_blank">https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse</a> <a href="#fnref:12" class="footnote-back-ref">↩</a></p></li> <li id="fn:13"><p>Nguyen, Brian T.; Nelson, Anita L. (December 2019). "Time for the US Food and Drug Administration approval of condoms for anal intercourse". eClinicalMedicine. 17: 100226. doi:10.1016/j.eclinm.2019.11.019. PMC 6933260. PMID 31891150. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933260" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933260</a> <a href="#fnref:13" class="footnote-back-ref">↩</a></p></li> <li id="fn:14"><p>Nguyen, Brian T.; Nelson, Anita L. (December 2019). "Time for the US Food and Drug Administration approval of condoms for anal intercourse". eClinicalMedicine. 17: 100226. doi:10.1016/j.eclinm.2019.11.019. PMC 6933260. PMID 31891150. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933260" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933260</a> <a href="#fnref:14" class="footnote-back-ref">↩</a></p></li> </ol>