Reducing Vaginal Infections in Women

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

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 douching, bathing, and sexual practices can influence the risk of vaginal infections. Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16 and older, living in Mombasa. Study procedures will include sexual behavior questions, physical examinations including pelvic exams, testing of vaginal and cervical secretions for STDs, urine collection and blood samples. Participants will receive 2 different types of pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no medication). Participants will be involved in study related procedures for 1 year and will return to the study clinic at one month intervals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Fluconazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.