AMP002 Phase III Contraceptive Study

Contraception Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Contraception

• NCT number: NCT03243305
• Study type: Interventional
• Source: Evofem Inc.
• Status: Completed
• Phase: Phase 3
• Start date: July 24, 2017
• Completion date: November 29, 2018