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 Jensen, Thomas D. Kimble, Amitasrigowri S. Murthy, Courtney A. Schreiber, Michael A. Thomas, Terri L. Walsh, Carolyn Westhoff, Anne E. Burke

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalContraception
DOIs
StatePublished - Jan 1 2019

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Condoms
Sexually Transmitted Diseases
Pregnancy
Contraceptive Agents
Female Condoms
Orgasm
Lubrication
Menstrual Cycle
Contraception
Esthetics

Keywords

  • Acceptability
  • Barrier methods
  • Contraception
  • Female condom
  • Internal condom
  • Woman's Condom

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Acceptability of the Woman's Condom in a phase III multicenter open-label study. / Chen, Beatrice A.; Blithe, Diana L.; Muraguri, Gitonga R.; Lance, Audrey A.; Carr, Bruce R.; Jensen, Jeffrey; Kimble, Thomas D.; Murthy, Amitasrigowri S.; Schreiber, Courtney A.; Thomas, Michael A.; Walsh, Terri L.; Westhoff, Carolyn; Burke, Anne E.

In: Contraception, 01.01.2019.

Research output: Contribution to journalArticle

Chen, BA, Blithe, DL, Muraguri, GR, Lance, AA, Carr, BR, Jensen, J, Kimble, TD, Murthy, AS, Schreiber, CA, Thomas, MA, Walsh, TL, Westhoff, C & Burke, AE 2019, 'Acceptability of the Woman's Condom in a phase III multicenter open-label study', Contraception. https://doi.org/10.1016/j.contraception.2019.02.006
Chen, Beatrice A. ; Blithe, Diana L. ; Muraguri, Gitonga R. ; Lance, Audrey A. ; Carr, Bruce R. ; Jensen, Jeffrey ; Kimble, Thomas D. ; Murthy, Amitasrigowri S. ; Schreiber, Courtney A. ; Thomas, Michael A. ; Walsh, Terri L. ; Westhoff, Carolyn ; Burke, Anne E. / Acceptability of the Woman's Condom in a phase III multicenter open-label study. In: Contraception. 2019.
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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.",
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AU - Blithe, Diana L.

AU - Muraguri, Gitonga R.

AU - Lance, Audrey A.

AU - Carr, Bruce R.

AU - Jensen, Jeffrey

AU - Kimble, Thomas D.

AU - Murthy, Amitasrigowri S.

AU - Schreiber, Courtney A.

AU - Thomas, Michael A.

AU - Walsh, Terri L.

AU - Westhoff, Carolyn

AU - Burke, Anne E.

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