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Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

NCT00542074 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2007-10-31

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis

Interventions

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®).

OTHER

hygienic information

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

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • King K. Holmes, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Completion
2005-08-31

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542074 on ClinicalTrials.gov