Comparative Efficacy of Ovule vs Tablet

August 4, 2015 updated by: Bayer

An Investigator-blinded, Active-controlled Phase 3 Study to Prove the Non-inferior Efficacy of a Clotrimazole Ovule (500 mg) Versus a Clotrimazole Vaginal Tablet (500 mg) in Vaginal Candidiasis

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

466

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hamburg, Germany, 22359
      • Hamburg, Germany, 22159
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
    • Bayern
      • München, Bayern, Germany, 80333
      • München, Bayern, Germany, 85356
    • Hessen
      • Frankfurt, Hessen, Germany, 65929
      • Fulda, Hessen, Germany, 36037
      • Wiesbaden, Hessen, Germany, 65197
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30459
      • Osnabrück, Niedersachsen, Germany, 49074
    • Nordrhein-Westfalen
      • Dortmund, Nordrhein-Westfalen, Germany, 44319
      • Krefeld, Nordrhein-Westfalen, Germany, 47799
      • Moscow, Russian Federation, 119049
      • Moscow, Russian Federation, 119002
      • Moscow, Russian Federation, 129090
      • Moscow, Russian Federation, 127473
      • Moscow, Russian Federation, 117198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.
  • Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).
  • Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.
  • Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
  • Negative saline smear for Trichomonas vaginalis

Exclusion Criteria:

  • Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.
  • Subjects presenting a protozoan infection as confirmed by microscopic investigation.
  • Pregnant, breast feeding or lactating subjects.
  • Subjects with suspected bacterial vaginal infection.
  • Subjects with abdominal pain, fever, or foul smelling vaginal discharge.
  • Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1.
  • Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial.
  • Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4).
  • Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4).
  • Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2).
  • Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months.
  • Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections.
  • Subjects who received another investigational drug within 30 days before visit 1.
  • Unwillingness to refrain from sexual activity during 3 days thereafter.
  • Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clotrimazole tablet (Canesten, BAY-B5097)
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Experimental: Clotrimazole ovule (Canesten, BAY-B5097)
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
Time Frame: 10-14 days after treatment (=visit 2)
10-14 days after treatment (=visit 2)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
Time Frame: 6-8 weeks after treatment (=visit 3)
6-8 weeks after treatment (=visit 3)
Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
Time Frame: 10-14 days after treatment (=visit 2)
10-14 days after treatment (=visit 2)
Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
Time Frame: 6-8 weeks after treatment (=visit 3)
6-8 weeks after treatment (=visit 3)
Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
Time Frame: 10-14 days after treatment (=visit 2)
10-14 days after treatment (=visit 2)
Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
Time Frame: 6-8 weeks after treatment (=visit 3)
6-8 weeks after treatment (=visit 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

July 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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