Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Conceptrol · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| Conceptrol | ACTIVE_COMPARATOR | 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel |
| Amphora | EXPERIMENTAL | Citric acid USP, potassium bitartrate USP, and L-lactic acid USP |
| Name | Type | Description |
|---|---|---|
| Conceptrol | DRUG | • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel. |
| Amphora | DRUG | • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel. |
Inclusion Criteria: * Be healthy women, who are sexually active, at risk for pregnancy, and desiring contraception. * Be within the age range of 18 through 35 (inclusive) at enrollment if not in the subset of women with an age of 36-45 at enrollment (age subset at select sites). * Be at low-risk fo...