Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
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|ClinicalTrials.gov Identifier: NCT01306331|
Recruitment Status : Completed
First Posted : March 1, 2011
Results First Posted : July 30, 2020
Last Update Posted : August 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Conceptrol Drug: Amphora||Phase 3|
Clinical Trial Design
This is a multicenter, open-label, randomized, controlled, Phase III study of repeated use of Amphora™ gel compared to Conceptrol® Vaginal Gel as the method of contraception over seven cycles of use. In addition, there is an opportunity for Amphora™ gel subjects to continue with study treatment for up to 13 cycles of treatment upon completion of the first seven cycles of treatment.
A subset of subjects (Amphora™ gel and Conceptrol® Vaginal Gel) will undergo colposcopy at the Admission Visit and at the visits after Cycles 1, 3, and 7 (Treatment Exit). Subjects participating for 13 cycles will also undergo colposcopy after Cycles 10 and 13. Colposcopic photographs will be taken at all visits independent of presence of any suspicious areas. Any suspicious areas and clinical findings will be recorded on the colposcopy case report form. The colposcopy evaluator for the subset will be blinded regarding the treatment group of the subject. If at any time during the study the investigator deems colposcopy necessary, colposcopy will be performed on any subject and will not be limited to subjects in the colposcopy subset.
A subset of subjects (Amphora™ gel and Conceptrol® Vaginal Gel) will also have semi-quantitative cultures for E. coli and clinical yeast performed at the Admission Visit and after Cycles 1, 3, and 7 (Treatment Exit) Visits. Subjects participating for 13 cycles will also undergo the assessments after Cycles 10 and 13. Another subgroup will have quantitative vaginal cultures performed after Cycles 1 and 7 (Treatment Exit) Visits, and also after Cycle 13 for subjects participating in the extension.
Selected research centers will also recruit subjects into the subset of women 36-45 years of age at enrollment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3389 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Randomized Study of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: Conceptrol
100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel
• Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
Citric acid USP, potassium bitartrate USP, and L-lactic acid USP
• Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
- 6-Month (183 Days) Cumulative Pregnancy Percentage [ Time Frame: 183 days ]The primary endpoint was the evaluation of contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the MITT population by treatment group
- 6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use [ Time Frame: 183 days ]Perfect use contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the efficacy evaluable (EE) population by treatment group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306331
|Study Director:||Kelly Culwell, MD||Evofem Inc.|