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Comparative Efficacy of Ovule vs Tablet

NCT00755053 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2015-08-06

No results posted yet for this study

Summary

The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)

Conditions

  • Clotrimazole
  • Ovulen
  • Vulvovaginal Candidiasis

Interventions

DRUG

Clotrimazole, vaginal ovule

Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

DRUG

Clotrimazole, vaginal tablet

Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Germany
  • Russia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00755053 on ClinicalTrials.gov