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Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

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ClinicalTrials.gov Identifier: NCT00542074
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : October 31, 2007
Sponsor:
Collaborators:
John E. Fogarty International Center (FIC)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
University of Washington

Brief Summary:
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 or disease Intervention/treatment Phase
Bacterial Vaginosis Other: hygienic information plus 62% ethyl alcohol in emollient gel Other: hygienic information Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
Study Start Date : June 2003
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. bacterial vaginosis by Nugent's score [ Time Frame: up to 2 months following treatment ]

Secondary Outcome Measures :
  1. presence of lactobacillus by culture [ Time Frame: 2 months following treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00542074


Locations
Kenya
Nairobi City Council STI referral clinic (Special Treatment Clinic)
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
John E. Fogarty International Center (FIC)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: King K. Holmes, MD, PhD University of Washington

ClinicalTrials.gov Identifier: NCT00542074     History of Changes
Other Study ID Numbers: 01-9276-001
R03TW005820 ( U.S. NIH Grant/Contract )
HD 40540-04
P30AI027757 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007

Keywords provided by University of Washington:
Bacterial vaginosis
recurrence
male factor

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Bacterial Infections
Recurrence
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Vaginitis
Emollients
Ethanol
Dermatologic Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs