Trial record 3 of 12 for:    bacterial vaginosis | NIH

Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

This study has been completed.
Sponsor:
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
  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:
Vaginosis, Bacterial
Bacterial Infections
Recurrence
Disease Attributes
Pathologic Processes
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 April 15, 2014