Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

Not Applicable

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Other: hygienic information plus 62% ethyl alcohol in emollient gel; Other: hygienic information

• Registration Number: NCT00542074
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2005-08
• Status Verified: 2007-10
• Study First Submitted: 2007-10-08
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Last Update Submitted: 2007-10-29
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

Not provided

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Exclusion Criteria

• Either male or female partner not recruited within 24 hours of the other

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	hygienic information plus 62% ethyl alcohol in emollient gel	-
2	hygienic information	-

Primary Outcome Measures

Name	Time	Method
bacterial vaginosis by Nugent's score	up to 2 months following treatment

Secondary Outcome Measures

Name	Time	Method
presence of lactobacillus by culture	2 months following treatment

Trial Locations

Locations (1)

Nairobi City Council STI referral clinic (Special Treatment Clinic); 🇰🇪 Nairobi, Kenya