CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,384 enrolled
Drug / intervention
AMPHORAdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03243305
NCT03243305Phase 3Completed
CompareCT.gov

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

Evofem Inc.·interventional·Posted Aug 9, 2017·Updated Sep 17, 2020

In Brief

A Phase 3 clinical trial evaluating AMPHORA for Contraception. Completed, enrolled 1,384 participants across 87 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 9, 2017
Enrollment StartJul 24, 2017
Primary CompletionNov 29, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.9 years ago

Interventions

AMPHORAdrug

non-hormonal contraceptive vaginal gel