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

International Partnership for Microbicides (IPM)

Status and phase

Completed

Early Phase 1

Conditions

HIV Infections

Treatments

Device: intravaginal ring

Study type

Interventional

Funder types

Industry

Identifiers

NCT00469170

IPM 011

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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