NCT04553068

Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection

Phase 3 Double-blind Placebo-controlled Efficacy Trial of EVO100 Vaginal Gel for the Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,892 (actual)
• Sponsor: Evofem Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection

Detailed description

In this phase 3 double blind placebo controlled, efficacy study, women who have had a urogenital chlamydia or gonorrhea infection at any time over the 16 weeks preceding the enrollment Visit with one or more risk factors, or found to be positive for either infection at Screening Visit with one or more risk factors will be enrolled. After a screening period of up to 35 days, women will be randomized to receive either EVO100 vaginal gel or placebo. Each woman will participate in the study until she has completed 16 weeks of study medication or observation or tests positive for CT or GC infection.

Conditions

• Sexually Transmitted Diseases
• Gonorrhea
• Chlamydia

Interventions

Type	Name	Description
DRUG	EVO100	EVO100 vaginal gel
DRUG	Placebo	Placebo vaginal gel

Timeline

• Start date: 2020-10-15
• Primary completion: 2022-07-28
• Completion: 2022-07-28
• First posted: 2020-09-17
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

98 sites across 1 country: United States

Regulatory

• FDA-regulated drug study