Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

This study has been completed.
Information provided by:
University of Washington Identifier:
First received: October 8, 2007
Last updated: October 29, 2007
Last verified: October 2007

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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00542074

Nairobi City Council STI referral clinic (Special Treatment Clinic)
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
Principal Investigator: King K. Holmes, MD, PhD University of Washington
  More Information

No publications provided 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
male factor

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Bacterial Infections
Disease Attributes
Genital Diseases, Female
Pathologic Processes
Vaginitis processed this record on August 27, 2015