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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-03-07

Brief Summary

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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.

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intravaginal Ring

Insertion of intravaginal ring at enrollment. The intravaginal ring should stay in place for 12 consecutive weeks and will be removed by a physician at the Week 12 study visit.

Group Type EXPERIMENTAL

Non-medicated Intravaginal Ring

Intervention Type DRUG

Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.

No Intravaginal Ring

Intravaginal ring will not be inserted into participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Placebo Intravaginal Ring

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes