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

Sexually Transmitted Diseases Clinical Trial

— EVOGUARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553068
• Other study ID #: EVO100-311
• Status: Completed
• Phase: Phase 3
• Start date: October 15, 2020
• Est. completion date: July 28, 2022

Study information

• Verified date: January 2024
• Source: Evofem Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1892
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia
• Chlamydia Infections
• Gonorrhea
• Sexually Transmitted Diseases

Intervention

Drug:
• EVO100
EVO100 vaginal gel
• Placebo
Placebo vaginal gel

Locations

Country	Name	City	State
United States	Virginia Women's Health Associates	Annandale	Virginia
United States	Agile Clinical Research Trials, LLC	Atlanta	Georgia
United States	Visionaries Clinical Research, LLC	Atlanta	Georgia
United States	Ideal Clinical Research	Aventura	Florida
United States	Cahaba Medical Care	Birmingham	Alabama
United States	Boston Medical Center/Boston University Medical Campus	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Urgent Care Clinical Trials @ AFC Urgent Care-Bronx	Bronx	New York
United States	Accellacare	Charlotte	North Carolina
United States	OnSite Clinical Solutions LLC	Charlotte	North Carolina
United States	MultiCare Health System - Rockwood Clinic Cheney	Cheney	Washington
United States	Eagle Clinical Research	Chicago	Illinois
United States	Research Network America	Chicago	Illinois
United States	Seven Hills Clinical Research Group	Cincinnati	Ohio
United States	Benchmark Research	Colton	California
United States	ClinOhio Research Services	Columbus	Ohio
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Complete Healthcare For Women	Columbus	Ohio
United States	Midtown OB GYN	Columbus	Georgia
United States	Coastal Bend Clinical Research	Corpus Christi	Texas
United States	AIDS Arms, Inc. DBA Prism Health North Texas	Dallas	Texas
United States	Cedar Health Research	Dallas	Texas
United States	Urgent Care Clinical Trials @City Doc Urgent Care - McKinney	Dallas	Texas
United States	Urgent Care Clinical Trials @City Doc Urgent Care-Inwood	Dallas	Texas
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Urgent Care Clinical Trials @ AFC Urgent Care-Easley	Easley	South Carolina
United States	Planned Parenthood of Northern, Central and Southern New Jersey	Elizabeth	New Jersey
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Onyx Clinical Research	Flint	Michigan
United States	Encore Medical Research, LLC	Hollywood	Florida
United States	University Women's Health Specialists	Honolulu	Hawaii
United States	Centex Studies, Inc.	Houston	Texas
United States	Cypress Harmony Research, LLC	Houston	Texas
United States	Encore Imaging and Medical Research, LLC	Houston	Texas
United States	Spring Family Practice Associates PA	Houston	Texas
United States	Synergy Groups Medical LLC	Houston	Texas
United States	Synergy Groups Medical LLC	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Join Clinical Trials	Huntington Park	California
United States	MacArthur Medical Center	Irving	Texas
United States	Lintecum and Nickell, P.C.	Kansas City	Missouri
United States	Maximos Ob/Gyn	League City	Texas
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Matrix Clinical Research	Los Angeles	California
United States	Centex Studies, Inc.	McAllen	Texas
United States	DCT-McAllen Primary Care Research dba Discovery Clinical Trials	McAllen	Texas
United States	WR-Medical Research Center of Memphis, LLC	Memphis	Tennessee
United States	Marchand OBGYN	Mesa	Arizona
United States	Homestead Associates in Research	Miami	Florida
United States	Pharmax Research of South Florida, Inc	Miami	Florida
United States	South Florida Research Center, Inc.	Miami	Florida
United States	US Associates in Research, LLC	Miami	Florida
United States	Planned Parenthood North Central States - Minneapolis	Minneapolis	Minnesota
United States	Synergy Groups Medical LLC	Missouri City	Texas
United States	Mobile Obstetrics & Gynecology, P.C.	Mobile	Alabama
United States	ASR,LLC	Nampa	Idaho
United States	Urgent Care Clinical Trials @ Complete Health Care Partners	Nashville	Tennessee
United States	Planned Parenthood of Southern New England	New Haven	Connecticut
United States	DelRicht Research	New Orleans	Louisiana
United States	Analyzed Health Clinical Trials	New York	New York
United States	Columbia University Irving Medical Center	New York	New York
United States	NYU Grossman School of Medicine/Bellevue Hospital Center	New York	New York
United States	TPMG Clinical Research	Newport News	Virginia
United States	The Group for Women	Norfolk	Virginia
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	Onyx Clinical Research	Peoria	Arizona
United States	Planned Parenthood of Northern, Central and Southern New Jersey	Perth Amboy	New Jersey
United States	ARC Clinical Research at Kelly Lane	Pflugerville	Texas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Planned Parenthood Southeastern Pennsylvania	Philadelphia	Pennsylvania
United States	Precision Trials AZ, LLC	Phoenix	Arizona
United States	UPMC Magee-Womens Hospital, Center for Family Planning Research	Pittsburgh	Pennsylvania
United States	Dream Team Clinical Research	Pomona	California
United States	Empire Clinical Research	Pomona	California
United States	Planned Parenthood Columbia Willamette	Portland	Oregon
United States	Urgent Care Clinical Trials @ AFC Urgent Care-Powdersville	Powdersville	South Carolina
United States	DelRicht Research	Prairieville	Louisiana
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	University of California, Davis Medical Center	Sacramento	California
United States	Planned Parenthood of the St. Louis Region and Southwest Missouri - Central West End Health Center	Saint Louis	Missouri
United States	The Contraceptive Choice Center/Center for Outpatient Health - Women's Health Center	Saint Louis	Missouri
United States	UC San Diego Health, Womens Health Services La Jolla	San Diego	California
United States	Urgent Care Clinical Trials @ AFC Urgent Care-Clemson	Seneca	South Carolina
United States	Renew Health Clinical Research	Snellville	Georgia
United States	Storks Research, LLC	Sugar Land	Texas
United States	Precision Clinical Research	Sunrise	Florida
United States	Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana, Kentucky - Tacoma Health Center	Tacoma	Washington
United States	Continental Clinical Solutions	Towson	Maryland
United States	DelRicht Research	Tulsa	Oklahoma
United States	Emerson Clinical Research Institute	Washington	District of Columbia
United States	Providere Research Inc	West Covina	California
United States	Comprehensive Clinical Research, LLC	West Palm Beach	Florida
United States	Circuit Clinical/OB GYN Associates of WNY	West Seneca	New York
United States	Encore Medical Research of Weston, LLC	Weston	Florida
United States	Across the LifeSpan, PLLC	Yanceyville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Evofem Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate Safety of EVO100: AEs	Descriptive analysis of AEs	16 weeks