Reducing Vaginal Infections in Women

NCT00170430 | Completed Phase 3

• 3 other identifiers: 20486-A01-0777-A 0102-125
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bacterial Diseases; Other Mycoses; Sexually Transmitted Infection

Keywords

HIV-1, sexually transmitted diseases, females, Kenya

Interventions

Fluconazole DRUG

Metronizadole DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Ganjoni Municipal Communicable Diseases Control Centre

Mombasa, Kenya

Location

MeSH Terms

Conditions

Bacterial Infections; Sexually Transmitted Diseases

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• R. Scott McClelland, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 18, 2010

Record last verified: 2010-03

Locations

KE (1)