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

International Partnership for Microbicides (IPM) logo

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

Trial design

220 participants in 2 patient groups

A
Experimental group
Description:
vaginal ring first 12 weeks & observational safety last 12 weeks
Treatment:
Device: intravaginal ring
B
Experimental group
Description:
observational safety first 12 weeks & vaginal ring last 12 weeks
Treatment:
Device: intravaginal ring

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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