Trials / Completed
CompletedNCT03243305
AMP002 Phase III Contraceptive Study
AMPOWER A Single-arm, Phase III, Open Label, Multi-center, Study in Women Aged 18-35 Years of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Referred to as AMPHORA®) Contraceptive Vaginal Gel
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,384 (actual)
- Sponsor
- Evofem Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm, open-label, Phase III study in approximately 100 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
Detailed description
Through assessments including pelvic examination, laboratory procedures, and medical and gynecological history, subjects will be screened for eligibility in order to enroll approximately 1349 subjects into the study. After a screening period of up to 60 days, enrolled women will receive study drug. Each woman will participate in the study until after she has completed treatment during seven study cycles. Women who have individual cycles that do not meet the criteria for an evaluable cycle will not have those cycles replaced by subsequent cycles in order to provide a total of seven evaluable cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMPHORA | non-hormonal contraceptive vaginal gel |
Timeline
- Start date
- 2017-07-24
- Primary completion
- 2018-11-29
- Completion
- 2018-11-29
- First posted
- 2017-08-09
- Last updated
- 2020-09-17
- Results posted
- 2020-07-22
Locations
87 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03243305. Inclusion in this directory is not an endorsement.