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



Status:Recruiting
Conditions:Healthy Studies, Women's Studies
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:May 2011

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


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.


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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
2
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Bronx, New York 10457
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Bronx, NY
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