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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
Est. primary completion date
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


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
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