Status:
COMPLETED
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
Lead Sponsor:
International Partnership for Microbicides, Inc.
Conditions:
HIV Infections
Eligibility:
FEMALE
18-35 years
Phase:
EARLY_PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00469170
Start Date
March 1 2007
End Date
February 1 2010
Last Update
November 15 2010
Active Locations (4)
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1
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg, South Africa
2
South African Medical Research Council
Durban, KwaZulu-Natal, South Africa, 4067
3
Desmond Tutu HIV Foundation, Masiphumelele
Cape Town, South Africa, 7975
4
Kilimanjaro Reproductive Health Program
Moshi, Tanzania