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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00140764
Other study ID # METRO STUDY
Secondary ID
Status Completed
Phase Phase 3
First received August 30, 2005
Last updated August 9, 2011
Start date January 2003
Est. completion date March 2005

Study information

Verified date August 2011
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority Malawi: College of Medicine Research and Ethics CommitteeUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

This is a phase 3, randomized, double masked, two arms study conducted in Malawi, Southeast Africa. The study is conducted among nonpregnant HIV infected or uninfected women of reproductive age. Intermittent mass treatment approaches are followed where women are randomized to antibiotic intravaginal treatment or placebo at enrollment. Women receive assigned product every three months for one year.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Metronidazole gel versus placebo gel


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of bacterial vaginosis
Primary Reported genitourinary symptoms
See also
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