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Completed

NCT Number: NCT00542074

Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nairobi City Council STI referral clinic (Special Treatment Clinic)

Nairobi, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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®).

Other names: Purell® (GOJO Healthcare Inc., Akron, OH)

hygienic information

Other

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

Primary outcomes

  1. bacterial vaginosis by Nugent's score

    Time frame: up to 2 months following treatment

Secondary outcomes

  1. presence of lactobacillus by culture

    Time frame: 2 months following treatment

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Oct 10, 2007
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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