Clinical Trial: Phase 2B Double-blinded Placebo-controlled Efficacy Trial of Amphora® Gel

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase 2B Double-blinded Placebo-controlled Efficacy Trial of Amphora® Gel for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection

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

Detailed Summary:

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 IVAG 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.

Sponsor: Evofem Inc.

Current Primary Outcome: One urogenital CT infection [ Time Frame: 24 weeks ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: One urogenital GC infection [ Time Frame: 24 weeks ]

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


Original Secondary Outcome: Same as current

Information By: Evofem Inc.

Dates:
Date Received: March 29, 2017
Date Started: May 2017
Date Completion: May 2019
Last Updated: April 4, 2017
Last Verified: April 2017