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62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides

NCT00469547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-04-30

No results posted yet for this study

Summary

The purpose of this study is to look at the safety and acceptance of using a microbicide (product that kills germs) gel to clean the genital area. Microbicide gel is used by hospital workers to clean their hands to kill germs. Researchers hope to use information from this study to conduct a larger study to determine if the microbicidal gel protects men against sexually transmitted infections, including HIV. Thirty healthy uncircumcised Kenyan men, 18 years and older, working in the fishing industry in Kisumu will be recruited. Participants will complete a questionnaire about their background and sexual practices. A researcher will conduct a detailed examination of the genital area with a magnifying glass. A blood and urine sample will be collected to test for infection. Each participant will use both the microbicidal gel and a placebo (contains no active ingredient) gel at different times during the study, and the results will be compared. Volunteers will participate up to 8 weeks.

Conditions

  • Sexually Transmitted Infections

Interventions

OTHER

62% ethanol in emollient gel

62% ethanol in emollient gel used as a topical male microbicide

DRUG

Placebo

15% ethanol in emollient gel used as a topical male microbicide

OTHER

15% ethanol in emollient gel

15% ethanol in emollient gel used as a topical male microbicide

Sponsors & Collaborators

Principal Investigators

  • King K Holmes, MD, PhD · University of Washington

  • Elizabeth Bukusi, MBChB, MPH, PhD · Kenya Medical Research Institute/University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Kenya

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00469547 on ClinicalTrials.gov