Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
This study has been completed.
Sponsor:
University of Washington
Collaborators:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00542074
First received: October 8, 2007
Last updated: October 29, 2007
Last verified: October 2007
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bacterial Vaginosis |
Other: hygienic information plus 62% ethyl alcohol in emollient gel Other: hygienic information |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence |
Further study details as provided by University of Washington:
Primary Outcome Measures:
- bacterial vaginosis by Nugent's score [ Time Frame: up to 2 months following treatment ]
Secondary Outcome Measures:
- presence of lactobacillus by culture [ Time Frame: 2 months following treatment ]
| Enrollment: | 223 |
| Study Start Date: | June 2003 |
| Study Completion Date: | August 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Other: hygienic information plus 62% ethyl alcohol in emollient gel
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 Name: Purell® (GOJO Healthcare Inc., Akron, OH)
|
| Active Comparator: 2 |
Other: hygienic information
Couples received a brochure with information on control of STI and good hygienic practices.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542074
Locations
| Kenya | |
| Nairobi City Council STI referral clinic (Special Treatment Clinic) | |
| Nairobi, Kenya | |
Sponsors and Collaborators
University of Washington
Investigators
| Principal Investigator: | King K. Holmes, MD, PhD | University of Washington |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00542074 History of Changes |
| Other Study ID Numbers: | 01-9276-001, R03 TW05820, HD 40540-04, P30 AI027757 |
| Study First Received: | October 8, 2007 |
| Last Updated: | October 29, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
Bacterial vaginosis recurrence male factor |
Additional relevant MeSH terms:
|
Recurrence Vaginosis, Bacterial Disease Attributes Pathologic Processes Bacterial Infections Vaginitis Vaginal Diseases Genital Diseases, Female Ethanol |
Emollients Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013