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

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00469170
First received: May 3, 2007
Last updated: November 10, 2010
Last verified: November 2010

May 3, 2007
November 10, 2010
March 2007
February 2010   (final data collection date for primary outcome measure)
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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.
  • 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
Complete list of historical versions of study NCT00469170 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women

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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Device: intravaginal ring
silicone elastomer intravaginal ring containing no drug product
  • Experimental: A
    vaginal ring first 12 weeks & observational safety last 12 weeks
    Intervention: Device: intravaginal ring
  • Experimental: B
    observational safety first 12 weeks & vaginal ring last 12 weeks
    Intervention: Device: intravaginal ring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa,   Tanzania
 
NCT00469170
IPM 011
Yes
Annalene Nel, International Partnership for Microbicides
International Partnership for Microbicides, Inc.
Not Provided
Study Director: Dr. Annalene Nel IPM
International Partnership for Microbicides, Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP