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Clinical Trials/NCT00694928
NCT00694928
Completed
Phase 3

Vaginal Infection Study 2

Lumara Health, Inc.73 sites in 2 countries843 target enrollmentMay 2008
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ConditionsVaginal Infection
Interventionsclindamycin phosphate/butoconazole nitratebutoconazole nitrate
Drugsclindamycin phosphate/butoconazole nitratebutoconazole nitrate

Overview

Phase
Phase 3
Intervention
clindamycin phosphate/butoconazole nitrate
Conditions
Vaginal Infection
Sponsor
Lumara Health, Inc.
Enrollment
843
Locations
73
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 another vaginal product in the treatment of vaginal infections.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
November 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

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 (73)

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