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Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
hygienic information plus 62% ethyl alcohol in emollient gel
hygienic information
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Vaginosis focused on measuring Bacterial vaginosis, recurrence, male factor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nairobi City Council STI referral clinic (Special Treatment Clinic)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

bacterial vaginosis by Nugent's score

Secondary Outcome Measures

presence of lactobacillus by culture

Full Information

First Posted
October 8, 2007
Last Updated
October 29, 2007
Sponsor
University of Washington
Collaborators
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)
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1. Study Identification

Unique Protocol Identification Number
NCT00542074
Brief Title
Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
Official Title
Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington
Collaborators
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)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
Bacterial vaginosis, recurrence, male factor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
hygienic information plus 62% ethyl alcohol in emollient gel
Other Intervention Name(s)
Purell® (GOJO Healthcare Inc., Akron, OH)
Intervention Description
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®).
Intervention Type
Other
Intervention Name(s)
hygienic information
Intervention Description
Couples received a brochure with information on control of STI and good hygienic practices.
Primary Outcome Measure Information:
Title
bacterial vaginosis by Nugent's score
Time Frame
up to 2 months following treatment
Secondary Outcome Measure Information:
Title
presence of lactobacillus by culture
Time Frame
2 months following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
King K. Holmes, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nairobi City Council STI referral clinic (Special Treatment Clinic)
City
Nairobi
Country
Kenya

12. IPD Sharing Statement

Learn more about this trial

Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

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