NCT00140764

Brief Summary

The purpose of this intervention is to find out whether intravaginal treatment with a gel containing an antibiotic (metronidazole), compared to a similar placebo gel (without antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection among African women who are HIV uninfected or HIV infected. The study will also determine the effect of these vaginal gels on genitourinary symptoms.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

August 10, 2011

Status Verified

August 1, 2011

First QC Date

August 30, 2005

Last Update Submit

August 9, 2011

Conditions

Bacterial VaginosisTrichomonas VaginitisUrogenital Diseases

Keywords

Genitourinary symptoms

Outcome Measures

Primary Outcomes (2)

  • Prevalence of bacterial vaginosis

  • Reported genitourinary symptoms

Interventions

Metronidazole gel versus placebo gelDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

  • Nonpregnant HIV-Uninfected HIV-Infected

You may not qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Aizire J, Dadabhai S, Taulo F, Makanani B, Gadama L, Sun J, Tsui A, Taha TE. Use of effective family planning methods and frequency of sex among HIV-infected and HIV-uninfected African women. Contracept Reprod Med. 2018 Jul 9;3:10. doi: 10.1186/s40834-018-0063-z. eCollection 2018.

    PMID: 30002871DERIVED

MeSH Terms

Conditions

Vaginosis, BacterialTrichomonas VaginitisUrogenital Diseases

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital DiseasesTrichomonas InfectionsProtozoan InfectionsParasitic Diseases

Study Officials

  • Taha E Taha, MD PHD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

January 1, 2003

Study Completion

March 1, 2005

Last Updated

August 10, 2011

Record last verified: 2011-08