Reducing Vaginal Infections in Women
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ClinicalTrials.gov Identifier: NCT00170430 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: March 18, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bacterial Diseases Other Mycoses Sexually Transmitted Infection | Drug: Fluconazole Drug: Metronizadole | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Reducing Vaginal Infections in Women at Risk for HIV-1 |
Study Start Date : | May 2003 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |


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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170430
Kenya | |
Ganjoni Municipal Communicable Diseases Control Centre | |
Mombasa, Kenya |
Principal Investigator: | R. Scott McClelland, MD, MPH | University of Washington |
Responsible Party: | Dr. Scott McClelland, University of Washington |
ClinicalTrials.gov Identifier: | NCT00170430 History of Changes |
Other Study ID Numbers: |
20486-A 01-0777-A 01 ( Other Identifier: University of Washington Human Subjects Division ) 02-125 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | March 18, 2010 |
Last Verified: | March 2010 |
Keywords provided by University of Washington:
HIV-1, sexually transmitted diseases, females, Kenya |
Additional relevant MeSH terms:
Infection Communicable Diseases Mycoses Sexually Transmitted Diseases Bacterial Infections Virus Diseases Genital Diseases, Male Genital Diseases, Female Fluconazole Antifungal Agents Anti-Infective Agents |
14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors |