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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    1730
  • sponsor
    Evofem Inc.
Updated on 22 September 2021
tubal ligation
computed tomography

Summary

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

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.

Details
Condition Chlamydia, Female Genital Diseases, Gonorrhea, Venereal disease, Viral infection, Chlamydial infection, Gynecological Infections, Sexually Transmitted Diseases (STDs), Sexually Transmitted Infection, Viral Infections, sexually transmitted disease, sexually transmitted diseases, sexually transmitted infections, chlamydia infections
Treatment Placebo, EVO100
Clinical Study IdentifierNCT04553068
SponsorEvofem Inc.
Last Modified on22 September 2021

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