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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
860
Urogenital CT Infection
Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
Time frame: 16 weeks
Urogenital GC Infection
Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).
Time frame: 16 weeks
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Mobile OB-GYN, PC
Mobile, Alabama, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Precision Trials AZ, LLC
Phoenix, Arizona, 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
Medical Center for Clinical Research - Wake Research
San Diego, California, United States
Optimus Medical Group, Inc.
San Francisco, California, United States
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