@article{3e2f8db3d7554bd096bb38b98aa6252e,
title = "Acceptability of the Woman's Condom in a phase III multicenter open-label study",
abstract = "Objective: This study aimed to evaluate the acceptability of the Woman's Condom (WC) over 6 months (183 days) and ≥6 menstrual cycles in a US-based multicenter open-label phase III contraceptive efficacy trial. Study design: We assessed acceptability via written questionnaire at visit 2 (after the third cycle) and visit 3 (after the sixth cycle or >183 days, or upon early discontinuation). Key domains included ease of use, comfort/lubrication, sexual satisfaction, male partner satisfaction and confidence in pregnancy and sexually transmitted infection (STI) prevention. We analyzed quantitative data using descriptive statistics. We conducted a content analysis to identify major themes from four open-ended questions. Results: Most women [327/405 (81%)] had limited or no previous experience with female (internal) condoms. Of 405 evaluable women, 346 women completed questionnaires at visit 2 and 303 women at visit 3; 282 women attended both visits. Of women attending both visits, 165/282 (59%) reported at visit 2 that WC insertion was easy/very easy; this increased to 195/282 (69%) at visit 3 (p=.03). Many women [166/281 (59%)] preferred the WC [105/281 (37%)] or were neutral [61/281 (22%)], while 115/281 (41%) preferred male condoms. Women attending visit 3 felt confident that the WC could prevent pregnancy [246/303 (81%)] and STIs [217/303 (72%)]. Many women expressed empowerment with having control over their contraception; some disliked the design, esthetics and insertion process. Most women (254/299 (85%)] would recommend the WC to a friend. Conclusion: The WC's acceptability and ease of use is promising for wider dissemination as a female-controlled method that can protect against both pregnancy and STIs. Implications: The WC's overall acceptability and ease of use is promising for a new female-controlled barrier contraceptive option that can protect against both pregnancy and sexually transmitted infections.",
keywords = "Acceptability, Barrier methods, Contraception, Female condom, Internal condom, Woman's Condom",
author = "Chen, {Beatrice A.} and Blithe, {Diana L.} and Muraguri, {Gitonga R.} and Lance, {Audrey A.} and Carr, {Bruce R.} and Jensen, {Jeffrey T.} and Kimble, {Thomas D.} and Murthy, {Amitasrigowri S.} and Schreiber, {Courtney A.} and Thomas, {Michael A.} and Walsh, {Terri L.} and Carolyn Westhoff and Burke, {Anne E.}",
note = "Funding Information: We would like to acknowledge PATH for their work on developing the WC and provision of study product, and CONRAD as regulatory sponsor of the Woman's Condom Effectiveness Study.☆ Conflicts of interest: Dr. Chen has received research support through Medicines360, Merck and Sebela, all managed through the Magee-Womens Research Institute, and serves on a Merck & Co. advisory board. Dr. Blithe is an employee of the NIH and is principal investigator of a Cooperative Research and Development Agreement between NICHD and HRA Pharma. Dr. Muraguri has no conflicts of interest. Dr. Lance is a Nexplanon trainer for Merck. Dr. Carr receives grant support and consults for AbbVie, receives grant support from Synteract (Medicines360) and serves on the data safety and monitoring board for Repros Therapeutics. Dr. Jensen has received payments for consulting from AbbVie, Cooper Surgical, Bayer Healthcare, Merck, Sebela and the Population Council. He has received research support managed through OHSU from AbbVie, Bayer Healthcare, Dar{\'e}, Estetra SPRL, Medicines360, Merck and Sebela. These companies and organizations may have a commercial or financial interest in the results of this research and technology. These potential conflicts of interest have been reviewed and managed by OHSU. Dr. Kimble has received research support from Medicines360, Allergan, Inovio, Antiva, Sebela, Mithra, AbbVie, Agile and Chemo, and is on a speaker's bureau for Merck Pharmaceuticals, AbbVie and Lupin Pharmaceuticals. Dr. Murthy has received research funding from Mithra. She is a Nexplanon trainer for Merck and a ParaGard trainer for Teva/Cooper Surgical. Dr. Schreiber has received research support through ContraMed (Sebela), Bayer Healthcare, Medicines360 and Dare Bioscience, all managed through the University of Pennsylvania Perelman School of Medicine. Dr. Thomas has received research support through Agile Therapeutics, Bayer Healthcare and Medicines360, all managed through the University of Cincinnati College of Medicine. Ms. Walsh has no conflicts of interest. Dr. Westhoff is a consultant to Merck, Bayer and Agile Therapeutics, and receives research support from Estetra SPRL, Leon Farma, Sebela and Medicines360, all managed through Columbia University. Dr. Burke has received research support from Bayer and Leon Farma, managed through Johns Hopkins University. Funding: This work was funded by the National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Contraceptive Clinical Trials Network. Publisher Copyright: {\textcopyright} 2019",
year = "2019",
month = jun,
doi = "10.1016/j.contraception.2019.02.006",
language = "English (US)",
volume = "99",
pages = "357--362",
journal = "Contraception",
issn = "0010-7824",
publisher = "Elsevier USA",
number = "6",
}