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

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

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

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; Chlamydia; Gonorrhea
• Intervention / Treatment: Drug: EVO100; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1892
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35218
      • Cahaba Medical Care
    • Mobile, Alabama, United States, 36608
      • Mobile Obstetrics & Gynecology, P.C.
  • Arizona
    • Mesa, Arizona, United States, 85209
      • Marchand OBGYN
    • Peoria, Arizona, United States, 85381
      • Onyx Clinical Research
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ, LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • California
    • Colton, California, United States, 92324
      • Benchmark Research
    • Huntington Park, California, United States, 90255
      • Join Clinical Trials
    • Los Angeles, California, United States, 90057
      • Matrix Clinical Research
    • Pomona, California, United States, 91767
      • Dream Team Clinical Research
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center
    • San Diego, California, United States, 92037
      • UC San Diego Health, Womens Health Services La Jolla
    • West Covina, California, United States, 91790
      • Providere Research Inc
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Planned Parenthood of Southern New England
  • District of Columbia
    • Washington, District of Columbia, United States, 20011
      • Emerson Clinical Research Institute
  • Florida
    • Aventura, Florida, United States, 33180
      • Ideal Clinical Research
    • Hollywood, Florida, United States, 33021
      • Encore Medical Research, LLC
    • Miami, Florida, United States, 33032
      • Homestead Associates in Research
    • Miami, Florida, United States, 33175
      • Pharmax Research of South Florida, Inc
    • Miami, Florida, United States, 33135
      • South Florida Research Center, Inc.
    • Miami, Florida, United States, 33175
      • US Associates in Research, LLC
    • North Miami, Florida, United States, 33161
      • Healthcare Clinical Data, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Clintheory Healthcare Miami
    • Orlando, Florida, United States, 32819
      • Clinical Associates of Orlando, LLC
    • Pembroke Pines, Florida, United States, 33026
      • Bioresearch Institute Llc
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Research, LLC
    • Weston, Florida, United States, 33331
      • Encore Medical Research of Weston, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • AGILE Clinical Research Trials, LLC
    • Atlanta, Georgia, United States, 30318
      • Visionaries Clinical Research, LLC
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Columbus, Georgia, United States, 31901
      • Midtown OB GYN
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
    • Snellville, Georgia, United States, 30078
      • Renew Health Clinical Research
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • University Women's Health Specialists
  • Idaho
    • Nampa, Idaho, United States, 83687
      • ASR,LLC
  • Illinois
    • Chicago, Illinois, United States, 60621
      • Eagle Clinical Research
    • Chicago, Illinois, United States, 60643
      • Research Network America
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
      • DelRicht Research
    • Prairieville, Louisiana, United States, 70769
      • DelRicht Research
  • Maryland
    • Towson, Maryland, United States, 21204
      • Continental Clinical Solutions
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center/Boston University Medical Campus
  • Michigan
    • Flint, Michigan, United States, 48532
      • Onyx Clinical Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55408
      • Planned Parenthood North Central States - Minneapolis
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Lintecum and Nickell, P.C.
    • Saint Louis, Missouri, United States, 63108
      • Planned Parenthood of the St. Louis Region and Southwest Missouri - Central West End Health Center
    • Saint Louis, Missouri, United States, 63108
      • The Contraceptive Choice Center/Center for Outpatient Health - Women's Health Center
  • New Jersey
    • Elizabeth, New Jersey, United States, 07201
      • Planned Parenthood of Northern, Central and Southern New Jersey
    • Perth Amboy, New Jersey, United States, 08861
      • Planned Parenthood of Northern, Central and Southern New Jersey
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10465
      • Urgent Care Clinical Trials @ AFC Urgent Care-Bronx
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
    • New York, New York, United States, 10016
      • Analyzed Health Clinical Trials
    • New York, New York, United States, 10016
      • NYU Grossman School of Medicine/Bellevue Hospital Center
    • West Seneca, New York, United States, 14224
      • Circuit Clinical/OB GYN Associates of WNY
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • OnSite Clinical Solutions LLC
    • Charlotte, North Carolina, United States, 28209
      • Accellacare
    • Fayetteville, North Carolina, United States, 28303
      • Carolina Institute for Clinical Research
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
    • Yanceyville, North Carolina, United States, 27379
      • Across the LifeSpan, PLLC
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Seven Hills Clinical Research Group
    • Columbus, Ohio, United States, 43213
      • ClinOhio Research Services
    • Columbus, Ohio, United States, 43231
      • Complete Healthcare For Women
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • DelRicht Research
  • Oregon
    • Portland, Oregon, United States, 97236
      • Planned Parenthood Columbia Willamette
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Planned Parenthood Southeastern Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Magee-Womens Hospital, Center for Family Planning Research
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • Urgent Care Clinical Trials @ AFC Urgent Care-Easley
    • Powdersville, South Carolina, United States, 29611
      • Urgent Care Clinical Trials @ AFC Urgent Care-Powdersville
    • Seneca, South Carolina, United States, 29678
      • Urgent Care Clinical Trials @ AFC Urgent Care-Clemson
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • WR-Medical Research Center of Memphis, LLC
    • Nashville, Tennessee, United States, 37209
      • Urgent Care Clinical Trials @ Complete Health Care Partners
  • Texas
    • Corpus Christi, Texas, United States, 78413
      • Coastal Bend Clinical Research
    • Dallas, Texas, United States, 75251
      • Cedar Health Research
    • Dallas, Texas, United States, 75204
      • Urgent Care Clinical Trials @City Doc Urgent Care - McKinney
    • Dallas, Texas, United States, 75208
      • AIDS Arms, Inc. DBA Prism Health North Texas
    • Dallas, Texas, United States, 75209
      • Urgent Care Clinical Trials @City Doc Urgent Care-Inwood
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • Houston, Texas, United States, 77036
      • Synergy Groups Medical LLC
    • Houston, Texas, United States, 77061
      • Synergy Groups Medical LLC
    • Houston, Texas, United States, 77065
      • Cypress Harmony Research, LLC
    • Houston, Texas, United States, 77065
      • Encore Imaging and Medical Research, LLC
    • Houston, Texas, United States, 77379
      • Spring Family Practice Associates PA
    • Irving, Texas, United States, 75062
      • MacArthur Medical Center
    • League City, Texas, United States, 77573
      • Maximos OB/GYN
    • McAllen, Texas, United States, 78504
      • Centex Studies, Inc.
    • McAllen, Texas, United States, 78503
      • DCT-McAllen Primary Care Research dba Discovery Clinical Trials
    • Missouri City, Texas, United States, 77459
      • Synergy Groups Medical LLC
    • Pflugerville, Texas, United States, 78660
      • ARC Clinical Research at Kelly Lane
    • Sugar Land, Texas, United States, 77479
      • Storks Research, LLC
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Virginia Women's Health Associates
    • Newport News, Virginia, United States, 23606
      • TPMG Clinical Research
    • Norfolk, Virginia, United States, 23502
      • The Group for Women
  • Washington
    • Cheney, Washington, United States, 99004
      • MultiCare Health System - Rockwood Clinic Cheney
    • Tacoma, Washington, United States, 98405
      • Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana, Kentucky - Tacoma Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Subject Recruitment: EVOGUARDStudy.com/ct

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EVO100 gel; EVO100 vaginal gel, 5 g	Drug: EVO100; EVO100 vaginal gel
Placebo Comparator: Placebo gel; Placebo vaginal gel, 5 g	Drug: Placebo; Placebo vaginal gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Safety of EVO100: AEs	Descriptive analysis of AEs	16 weeks

Collaborators and Investigators

• Sponsor: Evofem Inc.
• Investigators: Study Director: Catherine Maher, PhD, Evofem Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Urogenital Diseases; Genital Diseases; Chlamydia Infections; Gonorrhea; Sexually Transmitted Diseases
• Other Study ID Numbers: EVO100-311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No