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

NCT04553068 | Completed Phase 3 Results FDA Drug

• 1 other identifier: EVO100-311
• Study Type: interventional
• Target: 1,892
• Locations: 1 country
• Sites: 98

Brief Summary

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

Conditions

Sexually Transmitted Diseases; Gonorrhea; Chlamydia

Outcome Measures

Primary Outcomes (1)

• Percentage of Study Successes in the EVO100 and Placebo Treatment Groups

  Percentage of subjects who are defined study successes among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.

  16 weeks

Secondary Outcomes (1)

• Evaluate Safety of EVO100: AEs

  16 weeks

Study Arms (2)

EVO100 gel

EXPERIMENTAL

EVO100 vaginal gel, 5 g

Drug: EVO100

Placebo gel

PLACEBO COMPARATOR

Placebo vaginal gel, 5 g

Drug: Placebo

Interventions

EVO100 DRUG

EVO100 vaginal gel

EVO100 gel

Placebo DRUG

Placebo vaginal gel

Placebo gel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females Only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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:
• 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

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

Sponsors & Collaborators

• Evofem Inc.: lead

Study Sites (98)

Cahaba Medical Care

Birmingham, Alabama, 35218, United States

Location

Mobile Obstetrics & Gynecology, P.C.

Mobile, Alabama, 36608, United States

Location

Marchand OBGYN

Mesa, Arizona, 85209, United States

Location

Onyx Clinical Research

Peoria, Arizona, 85381, United States

Location

Precision Trials AZ, LLC

Phoenix, Arizona, 85032, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Benchmark Research

Colton, California, 92324, United States

Location

Join Clinical Trials

Huntington Park, California, 90255, United States

Location

Matrix Clinical Research

Los Angeles, California, 90057, United States

Location

Dream Team Clinical Research

Pomona, California, 91767, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

UC San Diego Health, Womens Health Services La Jolla

San Diego, California, 92037, United States

Location

Providere Research Inc

West Covina, California, 91790, United States

Location

Planned Parenthood of Southern New England

New Haven, Connecticut, 06511, United States

Location

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20011, United States

Location

Ideal Clinical Research

Aventura, Florida, 33180, United States

Location

Encore Medical Research, LLC

Hollywood, Florida, 33021, United States

Location

Homestead Associates in Research

Miami, Florida, 33032, United States

Location

South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

Pharmax Research of South Florida, Inc

Miami, Florida, 33175, United States

Location

US Associates in Research, LLC

Miami, Florida, 33175, United States

Location

Healthcare Clinical Data, Inc.

North Miami, Florida, 33161, United States

Location

Clintheory Healthcare Miami

North Miami Beach, Florida, 33162, United States

Location

Clinical Associates of Orlando, LLC

Orlando, Florida, 32819, United States

Location

Bioresearch Institute Llc

Pembroke Pines, Florida, 33026, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Comprehensive Clinical Research, LLC

West Palm Beach, Florida, 33409, United States

Location

Encore Medical Research of Weston, LLC

Weston, Florida, 33331, United States

Location

Visionaries Clinical Research, LLC

Atlanta, Georgia, 30318, United States

Location

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

Location

Midtown OB GYN

Columbus, Georgia, 31901, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Renew Health Clinical Research

Snellville, Georgia, 30078, United States

Location

University Women's Health Specialists

Honolulu, Hawaii, 96826, United States

Location

ASR,LLC

Nampa, Idaho, 83687, United States

Location

Eagle Clinical Research

Chicago, Illinois, 60621, United States

Location

Research Network America

Chicago, Illinois, 60643, United States

Location

DelRicht Research

New Orleans, Louisiana, 70124, United States

Location

DelRicht Research

Prairieville, Louisiana, 70769, United States

Location

Continental Clinical Solutions

Towson, Maryland, 21204, United States

Location

Boston Medical Center/Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location

Onyx Clinical Research

Flint, Michigan, 48532, United States

Location

Planned Parenthood North Central States - Minneapolis

Minneapolis, Minnesota, 55408, United States

Location

Lintecum and Nickell, P.C.

Kansas City, Missouri, 64111, United States

Location

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

St Louis, Missouri, 63108, United States

Location

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

St Louis, Missouri, 63108, United States

Location

Planned Parenthood of Northern, Central and Southern New Jersey

Elizabeth, New Jersey, 07201, United States

Location

Planned Parenthood of Northern, Central and Southern New Jersey

Perth Amboy, New Jersey, 08861, United States

Location

Analyzed Health Clinical Trials

New York, New York, 10016, United States

Location

NYU Grossman School of Medicine/Bellevue Hospital Center

New York, New York, 10016, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Urgent Care Clinical Trials @ AFC Urgent Care-Bronx

The Bronx, New York, 10465, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Circuit Clinical/OB GYN Associates of WNY

West Seneca, New York, 14224, United States

Location

Accellacare

Charlotte, North Carolina, 28209, United States

Location

OnSite Clinical Solutions LLC

Charlotte, North Carolina, 28277, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Across the LifeSpan, PLLC

Yanceyville, North Carolina, 27379, United States

Location

Seven Hills Clinical Research Group

Cincinnati, Ohio, 45242, United States

Location

ClinOhio Research Services

Columbus, Ohio, 43213, United States

Location

Complete Healthcare For Women

Columbus, Ohio, 43231, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74133, United States

Location

Planned Parenthood Columbia Willamette

Portland, Oregon, 97236, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Planned Parenthood Southeastern Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Magee-Womens Hospital, Center for Family Planning Research

Pittsburgh, Pennsylvania, 15213, United States

Location

Urgent Care Clinical Trials @ AFC Urgent Care-Easley

Easley, South Carolina, 29640, United States

Location

Urgent Care Clinical Trials @ AFC Urgent Care-Powdersville

Powdersville, South Carolina, 29611, United States

Location

Urgent Care Clinical Trials @ AFC Urgent Care-Clemson

Seneca, South Carolina, 29678, United States

Location

WR-Medical Research Center of Memphis, LLC

Memphis, Tennessee, 38120, United States

Location

Urgent Care Clinical Trials @ Complete Health Care Partners

Nashville, Tennessee, 37209, United States

Location

Coastal Bend Clinical Research

Corpus Christi, Texas, 78413, United States

Location

Urgent Care Clinical Trials @City Doc Urgent Care - McKinney

Dallas, Texas, 75204, United States

Location

AIDS Arms, Inc. DBA Prism Health North Texas

Dallas, Texas, 75208, United States

Location

Urgent Care Clinical Trials @City Doc Urgent Care-Inwood

Dallas, Texas, 75209, United States

Location

Cedar Health Research

Dallas, Texas, 75251, United States

Location

Synergy Groups Medical LLC

Houston, Texas, 77036, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

Synergy Groups Medical LLC

Houston, Texas, 77061, United States

Location

Cypress Harmony Research, LLC

Houston, Texas, 77065, United States

Location

Encore Imaging and Medical Research, LLC

Houston, Texas, 77065, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Spring Family Practice Associates PA

Houston, Texas, 77379, United States

Location

MacArthur Medical Center

Irving, Texas, 75062, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

DCT-McAllen Primary Care Research dba Discovery Clinical Trials

McAllen, Texas, 78503, United States

Location

Centex Studies, Inc.

McAllen, Texas, 78504, United States

Location

Synergy Groups Medical LLC

Missouri City, Texas, 77459, United States

Location

ARC Clinical Research at Kelly Lane

Pflugerville, Texas, 78660, United States

Location

Storks Research, LLC

Sugar Land, Texas, 77479, United States

Location

Virginia Women's Health Associates

Annandale, Virginia, 22003, United States

Location

TPMG Clinical Research

Newport News, Virginia, 23606, United States

Location

The Group for Women

Norfolk, Virginia, 23502, United States

Location

MultiCare Health System - Rockwood Clinic Cheney

Cheney, Washington, 99004, United States

Location

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

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• 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.

  PMID: 35418329 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Gonorrhea; Chlamydia Infections

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Chlamydiaceae Infections

Results Point of Contact

• Title: Catherine Maher
• Organization: Evofem

cmaher@evofem.com

8585501900

Study Officials

• Catherine Maher, PhD

  Evofem Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: October 15, 2020
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Locations

US (98)