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A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method

NCT ID: NCT00469170

Last Updated: 2010-11-15

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

EARLY_PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-02-28

Brief Summary

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The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV-1 HIV seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

vaginal ring first 12 weeks \& observational safety last 12 weeks

Group Type EXPERIMENTAL

intravaginal ring

Intervention Type DEVICE

silicone elastomer intravaginal ring containing no drug product

B

observational safety first 12 weeks \& vaginal ring last 12 weeks

Group Type EXPERIMENTAL

intravaginal ring

Intervention Type DEVICE

silicone elastomer intravaginal ring containing no drug product

Interventions

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intravaginal ring

silicone elastomer intravaginal ring containing no drug product

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female, age 18-35 years
* Willing and able to provide written informed consent
* HIV-uninfected and otherwise healthy
* Self-reported sexually active
* On a stable hormonal contraceptive regimen
* Regular menstrual cycle
* Willing to refrain from use of vaginal products or objects during the study

Exclusion Criteria

* Currently pregnant or last pregnancy within 3 months prior to enrollment
* Currently breast-feeding
* Participated in any other research study within 30 days prior to enrollment;
* Symptomatic untreated vaginal infections within 2 weeks prior to enrollment
* Presence of abnormal physical finding on the vulva, vaginal walls or cervix
* History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction;
* Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
* Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
* Any serious acute, chronic or progressive disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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International Partnership for Microbicides

Principal Investigators

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Dr. Annalene Nel

Role: STUDY_DIRECTOR

Beijing Immupeutics Medicine Technology Limited

Locations

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Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic

Yeoville, Johannesburg, South Africa

Site Status

South African Medical Research Council

Durban, KwaZulu-Natal, South Africa

Site Status

Desmond Tutu HIV Foundation, Masiphumelele

Cape Town, , South Africa

Site Status

Kilimanjaro Reproductive Health Program

Moshi, , Tanzania

Site Status

Countries

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Kenya South Africa Tanzania

Other Identifiers

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IPM 011

Identifier Type: -

Identifier Source: org_study_id