Phase 2B/3 Double-blinded Placebo-controlled
- Registration Number
- NCT03107377
- Lead Sponsor
- Evofem Inc.
- Brief Summary
Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis infection
- Detailed Description
Primary: To determine if intravaginal EVO100 reduces the risk of urogenital Chlamydia trachomatis (CT) infection.
Secondary: To determine if intravaginal EVO100 reduces the risk of urogenital Neisseria gonorrhoeae (GC) infection.
Exploratory:To determine if EVO100 use rate (subject adherence to instructed use) has an effect on proportion of subjects who experience CT or GC infection during the study intervention period.
Primary Outcome Measures: Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
Secondary Outcome Measures: Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).
Exploratory Outcome Measures:
* Compliance with EVO100 usage during study (rate of product use adherence).
* Sensitivity analyses of the primary parameter (proportion of subjects who experience at least one CT or GC infection during the study intervention period) will be performed for the following:
* Subjects with ≥20%, ≥40%, ≥60% and ≥80% product use adherence
* Subject Satisfaction
* Sexual satisfaction
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 860
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Healthy female subjects between 18 and 45 years, inclusive
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Ability to understand the consent process and procedures
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Subjects agree to be available for all study visits
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Written informed consent in accordance with institutional guidelines
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Negative pregnancy test
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Negative CT and GC NAAT tests OR positive CT or GC NAAT and receives standard of care (SOC) treatment
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Agree to use a woman-controlled method of contraception, such as oral contraceptives, vaginal ring, birth control implants, IUDs, or tubal ligation (with the exception of spermicides, diaphragms, or any vaginally applied or inserted products containing nonoxynol-9). Condom use only is not an acceptable form of contraception for this study.
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Able and willing to comply with all study procedures
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Documented (as part of a retrievable medical record) CT or GC infection within 16 weeks prior to enrollment
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Reports vaginal sexual intercourse with a male partner at least 3 times per month in the previous month and anticipates vaginal sexual intercourse regularly for the duration of the study
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Agree to abstain from douching or any form of vaginal suppository use (other than study product) during course of study
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Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
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In the opinion of the Investigator, have a history of substance abuse in the last 12 months
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In the opinion of the Investigator, have 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
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Be an Evofem, ClinicalRM, or clinical site employee regardless of direct involvement in research activities, or their close relative
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Pregnant (or actively trying to become pregnant), or breast-feeding
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Women who have undergone a total hysterectomy (had uterus and cervix removed)
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Inability to provide informed consent
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A subject with a history or expectation of noncompliance with medications or intervention protocol
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Have engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device for 24 hours prior to enrollment (may be enrolled at a later date if all other criteria are met)
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Menstruating at enrollment (may be enrolled at a later date if all other criteria are met)
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Women who are currently being treated, or have been treated, for a period of 14 days prior to enrollment, with specific antibiotics known to be used for the treatment of CT or GC:
- Azithromycin
- Erythromycin
- Tetracycline
- Minocycline
- Doxycycline
- Levofloxacin
- Ofloxacin
- Ceftriaxone
- Cefixime
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In the opinion of the Investigator, has signs/symptoms that indicate persistence of chlamydia or gonorrhea 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.
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Women who regularly use douches, vaginal medications, products, or suppositories
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Women who are currently using contraceptive products that are directly delivered to the vaginal mucosa, such as diaphragms, vaginal rings (e.g. NuvaRing®), spermicides, or any vaginally applied or inserted products containing nonoxynol-9.
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Children, pregnant women, prisoners, and other vulnerable populations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse. EVO100 EVO100 A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
- Primary Outcome Measures
Name Time Method Urogenital CT Infection 16 weeks Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
- Secondary Outcome Measures
Name Time Method Urogenital GC Infection 16 weeks Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).
Trial Locations
- Locations (50)
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
CityDoc Urgent Care
🇺🇸Dallas, Texas, United States
Planned Parenthood Southeastern Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Magee Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Physician Care Clinical Research LLC
🇺🇸Sarasota, Florida, United States
Global Health Research Center
🇺🇸Miami Lakes, Florida, United States
Columbus Regional Research Institute - IACT Health
🇺🇸Columbus, Georgia, United States
John H. Stroger Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
Meridian Clinical Research
🇺🇸Richmond Hill, Georgia, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Precision Clinical Research
🇺🇸Lauderdale Lakes, Florida, United States
South Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Research Network America
🇺🇸Houston, Texas, United States
Centex Studios, Inc.
🇺🇸Houston, Texas, United States
S.E.Tx. Family Planning and Cancer Screening (SOGA)
🇺🇸Houston, Texas, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Medical Center for Clinical Research - Wake Research
🇺🇸San Diego, California, United States
Nevada Obstetrical Charity Clinic
🇺🇸Las Vegas, Nevada, United States
University of Cincinnati Physicians
🇺🇸Cincinnati, Ohio, United States
MedPharmics, LLC
🇺🇸Phoenix, Arizona, United States
Precision Trials AZ, LLC
🇺🇸Phoenix, Arizona, United States
Optimus Medical Group, Inc.
🇺🇸San Francisco, California, United States
Neere Bhatia, MD OB/GYN
🇺🇸San Antonio, Texas, United States
AFC Urgent Care Denver
🇺🇸Denver, Colorado, United States
Valley OB-GYN
🇺🇸Saginaw, Michigan, United States
ASR, LLC
🇺🇸Nampa, Idaho, United States
Mobile OB-GYN, PC
🇺🇸Mobile, Alabama, United States
Eclipse Clinical Research
🇺🇸Tucson, Arizona, United States
California Center for Clinical Research
🇺🇸Arcadia, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
United Clinical Research
🇺🇸Huntington Park, California, United States
Renew Health Clinical Research, LLC
🇺🇸Lawrenceville, Georgia, United States
DM Clinical Research
🇺🇸Alexandria, Louisiana, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
MedPharmics, LLD
🇺🇸Biloxi, Mississippi, United States
Bosque Women's Care
🇺🇸Albuquerque, New Mexico, United States
University of MS Medical Center
🇺🇸Jackson, Mississippi, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
PMG Research, Inc. - Wilmington Health
🇺🇸Wilmington, North Carolina, United States
Adams Patterson OB/GYN, Medical Research Center of Memphis
🇺🇸Memphis, Tennessee, United States
Invocare Clinical Research Center
🇺🇸West Columbia, South Carolina, United States
Premier Family Physicians
🇺🇸Austin, Texas, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States
Discovery MM Services, Inc.
🇺🇸Houston, Texas, United States
The Group for Women
🇺🇸Norfolk, Virginia, United States
North Texas Family Medicine
🇺🇸Plano, Texas, United States
Planned Parenthood of Southern New England
🇺🇸New Haven, Connecticut, United States