Status:
COMPLETED
Reducing Vaginal Infections in Women
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Diseases
Other Mycoses
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to see if taking medication once a month can help to decrease the risk of vaginal infections. Additionally, researchers will study whether personal habits, such as douchin...
Detailed Description
Prospective studies in Africa have demonstrated that vaginal infections are associated with a significant increase in a woman's risk of infection with HIV-1. Further clinical and epidemiological resea...
Eligibility Criteria
Inclusion
- Women who do not currently have symptoms of vaginal itching or discharge. Women with these symptoms may be treated and enrolled at a subsequent monthly visit when they are asymptomatic.
- Those who are currently menstruating may be enrolled after the completion of menses.
Exclusion
- Pregnancy
- Lactation
- History of adverse reactions to the study medications
- Alcoholism or inability to abstain from alcohol for 48 hours following treatment
- Women who do not anticipate living in Mombasa for a year following enrollment.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00170430
Start Date
May 1 2003
End Date
December 1 2006
Last Update
March 18 2010
Active Locations (1)
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1
Ganjoni Municipal Communicable Diseases Control Centre
Mombasa, Kenya