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Clinical Trial
. 2019 Jun;99(6):357-362.
doi: 10.1016/j.contraception.2019.02.006. Epub 2019 Mar 6.

Acceptability of the Woman's Condom in a phase III multicenter open-label study

Beatrice A Chen  1 , Diana L Blithe  2 , Gitonga R Muraguri  3 , Audrey A Lance  4 , Bruce R Carr  5 , Jeffrey T Jensen  6 , Thomas D Kimble  7 , Amitasrigowri S Murthy  8 , Courtney A Schreiber  9 , Michael A Thomas  10 , Terri L Walsh  11 , Carolyn Westhoff  12 , Anne E Burke  13
Affiliations
Clinical Trial

Acceptability of the Woman's Condom in a phase III multicenter open-label study

Beatrice A Chen et al. Contraception. 2019 Jun.

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.

Trial registration: ClinicalTrials.gov NCT01223313.

Keywords: Acceptability; Barrier methods; Contraception; Female condom; Internal condom; Woman's Condom.

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Conflict of interest statement

Conflicts of interest:

Dr. Chen has received research support through Medicines360 and Merck, all managed through the Magee-Womens Research Institute, and served on a Merck & Co. advisory board.

Dr. Blithe is an employee of the NIH and is principal investigator of a CRADA 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 Agile Therapeutics and Medicines 360, and serves on the data safety and monitoring board for Repros Therapeutics.

Dr. Jensen has received payments for consulting and research support from Bayer Healthcare, Merck, Agile Therapeutics, Abbvie, HRA Pharma, Teva, and the Population Council, consulting only from MicroChips and Evofem, and research support only from Estetra SPRL and Medicines360. 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 Medicines 360, Allergan, Inovio, Antiva, ContraMed, Agile, and Chemo, and is on a speaker’s bureau for Merck Pharmaceuticals.

Dr. Murthy has received research funding from Mithra. She is a Nexplanon trainer for Merck and a ParaGard trainer for Cooper Surgical.

Dr. Schreiber has received research support through ContraMed, Bayer Healthcare, and Medicines 360, all managed through the University of Pennsylvania Perelman School of Medicine.

Dr. Thomas has received research support through Agile Therapeutics, Bayer Healthcare, and Medicines 360, 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, Agile Therapeutics and Allergan and receives research support from Estetra SPRL, Leon Farma and Medicines360, all managed through Columbia University.

Dr. Burke has received research support from Bayer, Leon Farma, and healthy.io, managed through Johns Hopkins University.

Figures

Figure 1.
Figure 1.
Woman’s Condom, pre-insertion (pouch packaged inside a dissolvable capsule)
Figure 2.
Figure 2.
Flowchart of participants* * One enrollment protocol deviation occurred for a 41-year-old participant whose date of birth was incorrectly reported at screening. Missing questionnaires were due to participants not attending study visits or discontinuing early. Participants who discontinued early may have completed a questionnaire at time of discontinuation.
See this image and copyright information in PMC

References

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