- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00542074
Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
October 29, 2007 updated by: University of Washington
Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
223
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nairobi, Kenya
- Nairobi City Council STI referral clinic (Special Treatment Clinic)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Vaginal symptoms
- Nugent score > 6 for vaginal fluid gram stain
- Woman and her male partner both interested in study participation
- Woman able to return for follow-up visits
- Woman able to provide detailed contact information for tracing
Exclusion Criteria:
- Either male or female partner not recruited within 24 hours of the other
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
The male partner in each couple was asked to apply Purell® to his penis at least daily, and immediately prior to and following intercourse.
Couples received a brochure with information on control of STI and good hygienic practices.
Brochures for intervention and control arms were similar except the intervention arm brochure provided information on how to use the study product (Purell®).
Other Names:
|
Active Comparator: 2
|
Couples received a brochure with information on control of STI and good hygienic practices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
bacterial vaginosis by Nugent's score
Time Frame: up to 2 months following treatment
|
up to 2 months following treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
presence of lactobacillus by culture
Time Frame: 2 months following treatment
|
2 months following treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: King K. Holmes, MD, PhD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
October 8, 2007
First Submitted That Met QC Criteria
October 9, 2007
First Posted (Estimate)
October 10, 2007
Study Record Updates
Last Update Posted (Estimate)
October 31, 2007
Last Update Submitted That Met QC Criteria
October 29, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vaginitis
- Recurrence
- Vaginal Diseases
- Vaginosis, Bacterial
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Dermatologic Agents
- Ethanol
- Emollients
Other Study ID Numbers
- 01-9276-001
- P30AI027757 (U.S. NIH Grant/Contract)
- R03TW005820 (U.S. NIH Grant/Contract)
- HD 40540-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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CDA Research Group, Inc.TerminatedBacterial Vaginosis (BV)United States
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University of Alabama at BirminghamWayne State UniversityCompletedRecurrent Bacterial VaginosisUnited States
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Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
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Unity Health TorontoCompleted
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Mount Sinai Hospital, CanadaUnity Health TorontoCompletedPregnant Women Who Test Positive for Bacterial VaginosisCanada
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