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

Sexually Transmitted Diseases Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04553068
Study type Interventional
Source Evofem Inc.
Contact
Status Completed
Phase Phase 3
Start date October 15, 2020
Completion date July 28, 2022
View Details
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