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

NCT ID: NCT04553068

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1892 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2022-07-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

EVO100 gel

EVO100 vaginal gel, 5 g

Group Type: EXPERIMENTAL

EVO100

Intervention Type: DRUG

EVO100 vaginal gel

Placebo gel

Placebo vaginal gel, 5 g

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo vaginal gel

Interventions

EVO100

EVO100 vaginal gel

Intervention Type: DRUG

Placebo

Placebo vaginal gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects must meet both of the following criteria:

1. 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

2. 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Evofem Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Maher, PhD

Role: STUDY_DIRECTOR

Evofem Inc.

Locations

Cahaba Medical Care

Birmingham, Alabama, United States

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

Bioresearch Institute Llc

Pembroke Pines, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

Comprehensive Clinical Research, LLC

West Palm Beach, Florida, United States

Encore Medical Research of Weston, LLC

Weston, Florida, United States

Visionaries Clinical Research, LLC

Atlanta, Georgia, United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

Midtown OB GYN

Columbus, Georgia, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

iResearch Atlanta, LLC

Decatur, Georgia, United States

Renew Health Clinical Research

Snellville, Georgia, United States

University Women's Health Specialists

Honolulu, Hawaii, United States

ASR,LLC

Nampa, Idaho, United States

Eagle Clinical Research

Chicago, Illinois, United States

Research Network America

Chicago, Illinois, United States

DelRicht Research

New Orleans, Louisiana, United States

DelRicht Research

Prairieville, Louisiana, United States

Continental Clinical Solutions

Towson, Maryland, United States

Boston Medical Center/Boston University Medical Campus

Boston, Massachusetts, United States

Onyx Clinical Research

Flint, Michigan, United States

Planned Parenthood North Central States - Minneapolis

Minneapolis, Minnesota, United States

Lintecum and Nickell, P.C.

Kansas City, Missouri, United States

Planned Parenthood of the St. Louis Region and Southwest Missouri - Central West End Health Center

St Louis, Missouri, United States

The Contraceptive Choice Center/Center for Outpatient Health - Women's Health Center

St Louis, Missouri, United States

Planned Parenthood of Northern, Central and Southern New Jersey

Elizabeth, New Jersey, United States

Planned Parenthood of Northern, Central and Southern New Jersey

Perth Amboy, New Jersey, United States

Analyzed Health Clinical Trials

New York, New York, United States

NYU Grossman School of Medicine/Bellevue Hospital Center

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Urgent Care Clinical Trials @ AFC Urgent Care-Bronx

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Circuit Clinical/OB GYN Associates of WNY

West Seneca, New York, United States

Accellacare

Charlotte, North Carolina, United States

OnSite Clinical Solutions LLC

Charlotte, North Carolina, United States

Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Across the LifeSpan, PLLC

Yanceyville, North Carolina, United States

Seven Hills Clinical Research Group

Cincinnati, Ohio, United States

ClinOhio Research Services

Columbus, Ohio, United States

Complete Healthcare For Women

Columbus, Ohio, United States

DelRicht Research

Tulsa, Oklahoma, United States

Planned Parenthood Columbia Willamette

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Planned Parenthood Southeastern Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC Magee-Womens Hospital, Center for Family Planning Research

Pittsburgh, Pennsylvania, United States

Urgent Care Clinical Trials @ AFC Urgent Care-Easley

Easley, South Carolina, United States

Urgent Care Clinical Trials @ AFC Urgent Care-Powdersville

Powdersville, South Carolina, United States

Urgent Care Clinical Trials @ AFC Urgent Care-Clemson

Seneca, South Carolina, United States

WR-Medical Research Center of Memphis, LLC

Memphis, Tennessee, United States

Urgent Care Clinical Trials @ Complete Health Care Partners

Nashville, Tennessee, United States

Coastal Bend Clinical Research

Corpus Christi, Texas, United States

Urgent Care Clinical Trials @City Doc Urgent Care - McKinney

Dallas, Texas, United States

AIDS Arms, Inc. DBA Prism Health North Texas

Dallas, Texas, United States

Urgent Care Clinical Trials @City Doc Urgent Care-Inwood

Dallas, Texas, United States

Cedar Health Research

Dallas, Texas, United States

Synergy Groups Medical LLC

Houston, Texas, United States

Centex Studies, Inc.

Houston, Texas, United States

Synergy Groups Medical LLC

Houston, Texas, United States

Cypress Harmony Research, LLC

Houston, Texas, United States

Encore Imaging and Medical Research, LLC

Houston, Texas, United States

Texas Center for Drug Development, Inc.

Houston, Texas, United States

Spring Family Practice Associates PA

Houston, Texas, United States

MacArthur Medical Center

Irving, Texas, United States

Maximos Ob/Gyn

League City, Texas, United States

DCT-McAllen Primary Care Research dba Discovery Clinical Trials

McAllen, Texas, United States

Centex Studies, Inc.

McAllen, Texas, United States

Synergy Groups Medical LLC

Missouri City, Texas, United States

ARC Clinical Research at Kelly Lane

Pflugerville, Texas, United States

Storks Research, LLC

Sugar Land, Texas, United States

Virginia Women's Health Associates

Annandale, Virginia, United States

TPMG Clinical Research

Newport News, Virginia, United States

The Group for Women

Norfolk, Virginia, United States

MultiCare Health System - Rockwood Clinic Cheney

Cheney, Washington, United States

Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana, Kentucky - Tacoma Health Center

Tacoma, Washington, United States

Countries

United States

References

Thomas MA, Morlock R, Dart C, Howard B. Sexual Satisfaction Results With the Vaginal pH Modulator From the Phase 3 AMPOWER Study. J Sex Med. 2022 Jun;19(6):975-982. doi: 10.1016/j.jsxm.2022.03.221. Epub 2022 Apr 10.

Reference Type: DERIVED

PMID: 35418329 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EVO100-311

Identifier Type: -

Identifier Source: org_study_id