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

Completed · Phase 3 · Has a placebo group

Conditions studied: Sexually Transmitted Diseases, Gonorrhea, Chlamydia

In brief

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

Key facts

Study ID

NCT04553068

Run by

Evofem Inc.

People needed

1892

Starts

2020-10-15

Expected to finish

2022-07-28

Last updated by the study team

2024-01-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Subjects must meet both of the following criteria:
• Urogenital CT and/or GC infection (documented in a retrievable medical record) within the 16 weeks prior to enrollment and one or more of the additional risk factors included below:
• 18 to 24 years of age at the screening visit
• New sex partner within the past 12 weeks (84 days)
• More than one current sex partner
• Knowledge that current sex partner has multiple partners
• Partner with known sexually transmitted infection (STI)
• Inconsistent condom use among persons who are not in a mutually monogamous relationship
• After three unsuccessful documented attempts to obtain medical records, the subject has a self-reported history of infection less than 17 weeks prior to enrollment AND two or more of the following additional risk factors:
• 18 to 24 years of age at the screening visit
• New sex partner within the past 12 weeks (84 days)
• More than one current sex partner
• Knowledge that current sex partner has multiple partners
• Partner with known STI
• Inconsistent condom use among persons who are not in a mutually monogamous relationship
• Ability to understand the consent process and procedures. For minors, the ability to obtain consent from parents/legal guardian and assent by minor subjects as applicable according to local regulations.
• Agree to be available for all study visits including Visit 5 and follow-up Visit 6 and comply with follow-up on staff appointment reminders
• Negative pregnancy test
• Negative CT and GC nucleic acid amplification test (NAAT) at screening or positive CT or GC NAAT and receives standard of care (SOC according to CDC or World Health Organization [WHO] guidelines) treatment prior to enrollment with subsequent negative CT and GC NAAT testing at enrollment visit
• Agree to use a woman-controlled method of contraception that is not directly delivered to the vaginal mucosa (with the exception of a vaginal ring) throughout the duration of the study, such as oral contraceptives, birth control implants, intrauterine devices (IUDs), or tubal ligation. Condom use only is not an acceptable form of contraception for this study
• Able and willing to comply with all study procedures, including the use of eDiaries and reporting of all Adverse Events and concomitant medications.
• Reports vaginal sexual intercourse with a male partner at least three times per month in the previous month and anticipates vaginal sexual intercourse regularly for the duration of the study
• Agree to abstain from douching or any form of vaginal suppository use (other than investigational product) during course of study

You may not qualify if…

• In the opinion of the Investigator, has a history of substance or alcohol abuse in the last 12 months or, has issues, conditions, or concerns that may compromise the safety of the subject, impact the subject's compliance with the protocol requirements, or confound the reliability of the data acquired
• Women who have undergone a total hysterectomy (had uterus and cervix removed). However, women with subtotal hysterectomy with an intact cervix may be enrolled
• Has a history or expectation of noncompliance with medications or intervention protocol
• Has engaged in sexual vaginal intercourse or douching, or used of any form of vaginal suppository or intravaginal device (with the exception of contraceptive vaginal ring or tampons) for 24 hours prior to enrollment (may be enrolled at a later date if all other criteria are met)
• Menstruating at enrollment (may be enrolled at a later date if all other criteria are met)
• Is currently being treated, or has been treated, for a period of 21 days prior to enrollment, with any prohibited antibiotics. The prohibited antibiotics include azithromycin, erythromycin, doxycycline, levofloxacin, ofloxacin, ceftriaxone, and cefixime.
• In the opinion of the Investigator, has signs/symptoms that indicate persistence of CT or GC infection diagnosed at screening, new interval infection, and/or a failure to comply with or complete the prescribed treatment regimen following a positive screening NAAT

Where it is running

• Mobile Obstetrics & Gynecology, P.C. — Mobile, Alabama, United States
• Marchand OBGYN — Mesa, Arizona, United States
• Onyx Clinical Research — Peoria, Arizona, United States
• Precision Trials AZ, LLC — Phoenix, Arizona, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Benchmark Research — Colton, California, United States
• Join Clinical Trials — Huntington Park, California, United States
• Matrix Clinical Research — Los Angeles, California, United States
• Dream Team Clinical Research — Pomona, California, United States
• Empire Clinical Research — Pomona, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• UC San Diego Health, Womens Health Services La Jolla — San Diego, California, United States
• Providere Research Inc — West Covina, California, United States
• Planned Parenthood of Southern New England — New Haven, Connecticut, United States
• Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States
• Ideal Clinical Research — Aventura, Florida, United States
• Encore Medical Research, LLC — Hollywood, Florida, United States
• Homestead Associates in Research — Miami, Florida, United States
• South Florida Research Center, Inc. — Miami, Florida, United States
• Pharmax Research of South Florida, Inc — Miami, Florida, United States
• US Associates in Research, LLC — Miami, Florida, United States
• Healthcare Clinical Data, Inc. — North Miami, Florida, United States
• Clintheory Healthcare Miami — North Miami Beach, Florida, United States
• Clinical Associates of Orlando, LLC — Orlando, Florida, United States
• Cahaba Medical Care — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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