NCT01268332

Safety and Adherence of a Non-medicated Intravaginal Ring (IVR)

Expanded Safety and Adherence Study of a Non-medicated Intravaginal Ring

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Population Council · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR in HIV uninfected women over 12 weeks of use.

Detailed description

Women comprise a growing proportion of new HIV infections worldwide. Intravaginal rings (IVRs) used to deliver microbicides have the potential to significantly reduce the heterosexual transmission of HIV if found to be safe, acceptable, and effective against HIV infection. This study will investigate the safety and acceptability of a non-medicated silicone elastomer IVR in sexually active HIV uninfected women. The expected duration of this study for each participant is 16 weeks. Study participants will be randomly assigned to one of two arms. Participants in Group A will insert an IVR into their vagina at study entry. The IVR will remain in place for 12 weeks until removed by a physician. Follow up will continue for an additional 4 weeks after IVR removal. Participants in Group B will not receive an IVR, but will follow the same study schedule as those in Group A.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Non-medicated Intravaginal Ring	Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-09-01
• Completion: 2013-03-07
• First posted: 2010-12-30
• Last updated: 2017-08-15

Locations

3 sites across 2 countries: United States, India