Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

Bacterial Vaginosis Clinical Trial

Official title:

Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542074
• Other study ID #: 01-9276-001
• Secondary ID: R03TW005820HD 40
• Status: Completed
• Phase: N/A
• First received: October 8, 2007
• Last updated: October 29, 2007
• Start date: June 2003
• Est. completion date: August 2005

Study information

• Verified date: October 2007
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Recurrence
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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®).
• hygienic information
Couples received a brochure with information on control of STI and good hygienic practices.

Locations

Country	Name	City	State
Kenya	Nairobi City Council STI referral clinic (Special Treatment Clinic)	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), John E. Fogarty International Center (FIC), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial vaginosis by Nugent's score		up to 2 months following treatment
Secondary	presence of lactobacillus by culture		2 months following treatment