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

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 T.; 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, JT, 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 T. ; 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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AU - Blithe, Diana L.

AU - Muraguri, Gitonga R.

AU - Lance, Audrey A.

AU - Carr, Bruce R

AU - Jensen, Jeffrey T.

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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N2 - 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.

AB - 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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