Bacterial Vaginosis
Conditions
Keywords
Bacterial vaginosis, recurrence, male factor
Brief 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.
Interventions
OTHERhygienic 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®).
OTHERhygienic information
Couples received a brochure with information on control of STI and good hygienic practices.
Sponsors
Fogarty International Center of the National Institute of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bacterial vaginosis by Nugent's score | up to 2 months following treatment |
Secondary
| Measure | Time frame |
|---|---|
| presence of lactobacillus by culture | 2 months following treatment |
Countries
Kenya
Outcome results
None listed