Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

NCT00542074 | Completed

• 4 other identifiers: 01-9276-001R03TW005820HD 40540-04P30AI027757
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Keywords

Bacterial vaginosis; recurrence; male factor

Outcome Measures

Primary Outcomes (1)

• bacterial vaginosis by Nugent's score

  up to 2 months following treatment

Secondary Outcomes (1)

• presence of lactobacillus by culture

  2 months following treatment

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

Other: hygienic information

Interventions

hygienic information plus 62% ethyl alcohol in emollient gel OTHER

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®).

Also known as: Purell® (GOJO Healthcare Inc., Akron, OH)

1

hygienic information OTHER

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Nairobi City Council STI referral clinic (Special Treatment Clinic)

Nairobi, Kenya

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Recurrence

Interventions

Ethanol; hydroxide ion

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• King K. Holmes, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2007
• First Posted: October 10, 2007
• Study Start: June 1, 2003
• Study Completion: August 1, 2005
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

KE (1)