A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
Early Phase 1
Completed
- Conditions
- HIV Infections
- Interventions
- Device: intravaginal ring
- Registration Number
- NCT00469170
- Lead Sponsor
- International Partnership for Microbicides, Inc.
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 220
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A intravaginal ring vaginal ring first 12 weeks \& observational safety last 12 weeks B intravaginal ring observational safety first 12 weeks \& vaginal ring last 12 weeks
- Primary Outcome Measures
Name Time Method The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV. 3 months The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
🇿🇦Yeoville, Johannesburg, South Africa
South African Medical Research Council
🇿🇦Durban, KwaZulu Natal, South Africa
Desmond Tutu HIV Foundation, Masiphumelele
🇿🇦Cape Town, South Africa
Kilimanjaro Reproductive Health Program
🇹🇿Moshi, Tanzania