Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

University of Washington

Status: Completed

Conditions: Bacterial Vaginosis

Treatments: Other: hygienic information plus 62% ethyl alcohol in emollient gel; Other: hygienic information

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00542074

01-9276-001

HD 40540-04

R03TW005820 (U.S. NIH Grant/Contract)

P30AI027757 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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223 participants in 2 patient groups

1

Experimental group

Treatment:

Other: hygienic information plus 62% ethyl alcohol in emollient gel

2

Active Comparator group

Treatment:

Other: hygienic information