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

Completed · Phase 2 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01268332

Run by

Population Council

People needed

195

Starts

2011-05-01

Expected to finish

2013-03-07

Last updated by the study team

2017-08-15

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• HIV uninfected
• General good health
• Sexually active
• Agree to use an effective method of contraception
• Normal Pap smear result within 12 months prior to study entry
• Agree to not participate in other drug or device research studies for the duration of study participation
• Agree to not use any intravaginal product for the duration of study participation

You may not qualify if…

• History of adverse reaction to silicone, latex, or titanium dioxide
• Current male sex partner with known history of adverse reaction to silicone, latex, or titanium dioxide
• Last pregnancy outcome within 30 days or less prior to enrollment
• History of hysterectomy
• Any abnormal pelvic exam finding
• Pregnant
• Condition that, in the opinion of the investigator, would interfere with the study
• Severe pelvic relaxation

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Bronx-Lebanon Hospital Center — The Bronx, New York, United States
• National AIDS Research Institute — Pune, India

Full record on ClinicalTrials.gov

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