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Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542074
First Posted: October 10, 2007
Last Update Posted: October 31, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

Resource links provided by NLM:


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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: October 8, 2007
First Posted: October 10, 2007
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:
Recurrence
Vaginal Diseases
Vaginosis, Bacterial
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Bacterial Infections
Vaginitis
Emollients
Ethanol
Dermatologic Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs