Clinical trial NCT04553068: Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexually Transmitted Diseases
Gonorrhea
Chlamydia
Lead sponsor: Evofem Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 1892
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Study Successes in the EVO100 and Placebo Treatment Groups
timeFrame: 16 weeks
Secondary outcomes:
measure: Evaluate Safety of EVO100: AEs
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Medical Care
state: Alabama
city: Mobile
country: United States
facility: Mobile Obstetrics & Gynecology, P.C.
state: Alabama
city: Mesa
country: United States
facility: Marchand OBGYN
state: Arizona
city: Peoria
country: United States
facility: Onyx Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Colton
country: United States
facility: Benchmark Research
state: California
city: Huntington Park
country: United States
facility: Join Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Diego
country: United States
facility: UC San Diego Health, Womens Health Services La Jolla
state: California
city: West Covina
country: United States
facility: Providere Research Inc
state: California
city: New Haven
country: United States
facility: Planned Parenthood of Southern New England
state: Connecticut
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Aventura
country: United States
facility: Ideal Clinical Research
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Pharmax Research of South Florida, Inc
state: Florida
city: Miami
country: United States
facility: US Associates in Research, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Clintheory Healthcare Miami
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Bioresearch Institute Llc
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Research, LLC
state: Florida
city: Weston
country: United States
facility: Encore Medical Research of Weston, LLC
state: Florida
city: Atlanta
country: United States
facility: Visionaries Clinical Research, LLC
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Columbus
country: United States
facility: Midtown OB GYN
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Snellville
country: United States
facility: Renew Health Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: University Women's Health Specialists
state: Hawaii
city: Nampa
country: United States
facility: ASR,LLC
state: Idaho
city: Chicago
country: United States
facility: Eagle Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Research Network America
state: Illinois
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Prairieville
country: United States
facility: DelRicht Research
state: Louisiana
city: Towson
country: United States
facility: Continental Clinical Solutions
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center/Boston University Medical Campus
state: Massachusetts
city: Flint
country: United States
facility: Onyx Clinical Research
state: Michigan
city: Minneapolis
country: United States
facility: Planned Parenthood North Central States - Minneapolis
state: Minnesota
city: Kansas City
country: United States
facility: Lintecum and Nickell, P.C.
state: Missouri
city: Saint Louis
country: United States
facility: Planned Parenthood of the St. Louis Region and Southwest Missouri - Central West End Health Center
state: Missouri
city: Saint Louis
country: United States
facility: The Contraceptive Choice Center/Center for Outpatient Health - Women's Health Center
state: Missouri
city: Elizabeth
country: United States
facility: Planned Parenthood of Northern, Central and Southern New Jersey
state: New Jersey
city: Perth Amboy
country: United States
facility: Planned Parenthood of Northern, Central and Southern New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Urgent Care Clinical Trials @ AFC Urgent Care-Bronx
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Analyzed Health Clinical Trials
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicine/Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: West Seneca
country: United States
facility: Circuit Clinical/OB GYN Associates of WNY
state: New York
city: Charlotte
country: United States
facility: Accellacare
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions LLC
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Yanceyville
country: United States
facility: Across the LifeSpan, PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: Seven Hills Clinical Research Group
state: Ohio
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare For Women
state: Ohio
city: Tulsa
country: United States
facility: DelRicht Research
state: Oklahoma
city: Portland
country: United States
facility: Planned Parenthood Columbia Willamette
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Planned Parenthood Southeastern Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital, Center for Family Planning Research
state: Pennsylvania
city: Easley
country: United States
facility: Urgent Care Clinical Trials @ AFC Urgent Care-Easley
state: South Carolina
city: Powdersville
country: United States
facility: Urgent Care Clinical Trials @ AFC Urgent Care-Powdersville
state: South Carolina
city: Seneca
country: United States
facility: Urgent Care Clinical Trials @ AFC Urgent Care-Clemson
state: South Carolina
city: Memphis
country: United States
facility: WR-Medical Research Center of Memphis, LLC
state: Tennessee
city: Nashville
country: United States
facility: Urgent Care Clinical Trials @ Complete Health Care Partners
state: Tennessee
city: Corpus Christi
country: United States
facility: Coastal Bend Clinical Research
state: Texas
city: Dallas
country: United States
facility: Urgent Care Clinical Trials @City Doc Urgent Care - McKinney
state: Texas
city: Dallas
country: United States
facility: AIDS Arms, Inc. DBA Prism Health North Texas
state: Texas
city: Dallas
country: United States
facility: Urgent Care Clinical Trials @City Doc Urgent Care-Inwood
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical LLC
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical LLC
state: Texas
city: Houston
country: United States
facility: Cypress Harmony Research, LLC
state: Texas
city: Houston
country: United States
facility: Encore Imaging and Medical Research, LLC
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Houston
country: United States
facility: Spring Family Practice Associates PA
state: Texas
city: Irving
country: United States
facility: MacArthur Medical Center
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
city: McAllen
country: United States
facility: DCT-McAllen Primary Care Research dba Discovery Clinical Trials
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Missouri City
country: United States
facility: Synergy Groups Medical LLC
state: Texas
city: Pflugerville
country: United States
facility: ARC Clinical Research at Kelly Lane
state: Texas
city: Sugar Land
country: United States
facility: Storks Research, LLC
state: Texas
city: Annandale
country: United States
facility: Virginia Women's Health Associates
state: Virginia
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Norfolk
country: United States
facility: The Group for Women
state: Virginia
city: Cheney
country: United States
facility: MultiCare Health System - Rockwood Clinic Cheney
state: Washington
city: Tacoma
country: United States
facility: Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana, Kentucky - Tacoma Health Center
state: Washington
Study officials:
affiliation: Evofem Inc.
name: Catherine Maher, PhD
role: STUDY_DIRECTOR
References:
citation: 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.