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Clinical Trials/NCT00616330
NCT00616330CompletedPhase 3

Vaginal Infection Study

Lumara Health, Inc.130 sites in 1 country1,443 target enrollmentStarted: January 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,443
Locations
130
Primary Endpoint
Clinical symptom resolution.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Experimental

clindamycin phosphate/butoconazole nitrate

Intervention: clindamycin phosphate/butoconazole nitrate (Drug)

2

Active Comparator

clindamycin phosphate

Intervention: clindamycin phosphate (Drug)

3

Active Comparator

butoconazole nitrate

Intervention: butoconazole nitrate (Drug)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (130)

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