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

Beatrice A Chen; Diana L Blithe; Gitonga R Muraguri; Audrey A Lance; Bruce R Carr; Jeffrey T Jensen; Thomas D Kimble; Amitasrigowri S Murthy; Courtney A Schreiber; Michael A Thomas; Terri L Walsh; Carolyn Westhoff; Anne E Burke

doi:10.1016/j.contraception.2019.02.006

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

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

Authors

Affiliations

¹ Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, USA. Electronic address: chenba@upmc.edu.
² Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Dr, Bethesda, MD 20817, USA.
³ Health Decisions Inc., 2510 Meridian Parkway, Durham, NC 27713, USA.
⁴ Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA, USA; Northland Family Planning, 35000 Ford Road, Westland MI 48185, USA.
⁵ Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.
⁶ Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.
⁷ Department of Obstetrics and Gynecology, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA 23323, USA.
⁸ Department of Obstetrics and Gynecology, NYU School of Medicine, Bellevue Hospital Center, 462 First Ave, New York, NY 10016, USA.
⁹ Department of Obstetrics and Gynecology, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA.
¹⁰ Department of Obstetrics & Gynecology, University of Cincinnati Medical Center, 234 Goodman St, Cincinnati, OH 45219, USA.
¹¹ Essential Access Health, 3600 Wilshire Blvd, Suite 600, Los Angeles, CA 90010, USA.
¹² Department of Obstetrics & Gynecology, Columbia University, 622 West 168th St, PH 16, New York, NY 10032, USA.
¹³ Department of Gynecology & Obstetrics, Johns Hopkins University, 4940 Eastern Ave, Baltimore, MD 21224, USA.

PMID: 30849305
PMCID: PMC7363037
DOI: 10.1016/j.contraception.2019.02.006

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.

Publication types

Clinical Trial, Phase III
Multicenter Study
Research Support, N.I.H., Extramural

MeSH terms

Adolescent
Adult
Condoms, Female / statistics & numerical data*
Contraception Behavior
Family Planning Services
Female
Health Knowledge, Attitudes, Practice*
Humans
Patient Acceptance of Health Care / statistics & numerical data*
Pregnancy
Sexually Transmitted Diseases / prevention & control
Surveys and Questionnaires
United States
Women's Health
Young Adult

Associated data

ClinicalTrials.gov/NCT01223313

Grants and funding

Z99 HD999999/ImNIH/Intramural NIH HHS/United States