Last updated on September 2018

Phase 2B/3 Double-blinded Placebo-controlled


Brief description of study

Phase 2B double-blind placebo-controlled efficacy trial of Amphora gel for the prevention of acquisition of urogenital Chlamydia trachomatis infection

Detailed Study Description

Primary: To determine if intravaginal Amphora gel reduces the risk of urogenital Chlamydia trachomatis (CT) infection.

Secondary: To determine if intravaginal Amphora gel reduces the risk of urogenital Neisseria gonorrhoeae (GC) infection.

Exploratory:To determine if Amphora gel use rate (subject adherence to instructed use) has an effect on proportion of subjects who experience at least one CT or GC infection during the study intervention period.

Primary Outcome Measures: Proportion of subjects who experience at least one urogenital CT infection during the study intervention period (incident infection of CT).

Secondary Outcome Measures: Proportion of subjects who experience at least one urogenital GC infection during the study intervention period (incident infection of GC).

Exploratory Outcome Measures:

  • Compliance with Amphora gel 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

Clinical Study Identifier: NCT03107377

Contact Investigators or Research Sites near you

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Peyman Banooni, MD

United Clinical Research
Huntington Park, CA United States
3.23miles
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Recruitment Status: Open


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