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Clinical Trials/NCT00616330
NCT00616330
Completed
Phase 3

Vaginal Infection Study

Lumara Health, Inc.130 sites in 1 country1,443 target enrollmentJanuary 2008
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ConditionsVulvovaginitisVaginitis
Interventionsclindamycin phosphate/butoconazole nitrateclindamycin phosphatebutoconazole nitrate
Drugsclindamycin phosphate/butoconazole nitrateclindamycin phosphatebutoconazole nitrate

Overview

Phase
Phase 3
Intervention
clindamycin phosphate/butoconazole nitrate
Conditions
Vulvovaginitis
Sponsor
Lumara Health, Inc.
Enrollment
1443
Locations
130
Primary Endpoint
Clinical symptom resolution.
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
December 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patients must have a clinical diagnosis of vaginal infection.
  • •Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.

Exclusion Criteria

  • •Patients must not have any other infections
  • •May not be pregnant or nursing
  • •May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.

Arms & Interventions

1

clindamycin phosphate/butoconazole nitrate

Intervention: clindamycin phosphate/butoconazole nitrate

2

clindamycin phosphate

Intervention: clindamycin phosphate

3

butoconazole nitrate

Intervention: butoconazole nitrate

Outcomes

Primary Outcomes

Clinical symptom resolution.

Time Frame: baseline, 7 to 10 days and 21 to 30 days

Secondary Outcomes

  • Yeast Culture for Candida(baseline, 7 to 10 days and 21 to 30 days)
  • Gram stain Nugent score(baseline, 7 to 10 days and 21 to 30 days)
  • Saline wet mount for clue cells(baseline, 7 to 10 days and 21 to 30 days)

Study Sites (130)

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