Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Population Council
Study ID
NCT07039591
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Contraceptive Usage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Pro-type IVR — DEVICE
    Women will test three non-medicated IVRs on two one-day clinic visits (two on the first day, one on the second day) by manipulating them, vaginally inserting each ring and then performing a controlled set of tasks simulating routine daily activities with the ring in the vagina.

Study Details

A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA

Key Dates

Start date
Aug 8, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Proto-type IVR
    60 women comparing acceptability of three different non-medicated IVRs (2 silicone and 1 EVA) based on the Intravaginal Ring Acceptability Scale (IVR-AS).

Primary Outcome Measure

Mean Acceptability Score per IVR [ Time Frame: From enrollment to the end of treatment at approximately 13 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Jessica Sales, PhD
404-727-6598

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