- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00755053
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
Status
Completed
Conditions
Intervention / Treatment
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
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Hamburg, Germany, 22359
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Hamburg, Germany, 22159
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Baden-Württemberg
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Freiburg, Baden-Württemberg, Germany, 79106
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Bayern
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München, Bayern, Germany, 80333
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München, Bayern, Germany, 85356
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Hessen
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Frankfurt, Hessen, Germany, 65929
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Fulda, Hessen, Germany, 36037
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Wiesbaden, Hessen, Germany, 65197
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30459
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Osnabrück, Niedersachsen, Germany, 49074
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Nordrhein-Westfalen
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Dortmund, Nordrhein-Westfalen, Germany, 44319
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Krefeld, Nordrhein-Westfalen, Germany, 47799
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Moscow, Russian Federation, 119049
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Moscow, Russian Federation, 119002
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Moscow, Russian Federation, 129090
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Moscow, Russian Federation, 127473
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Moscow, Russian Federation, 117198
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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 |
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Active Comparator: Clotrimazole tablet (Canesten, BAY-B5097)
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
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Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
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Experimental: Clotrimazole ovule (Canesten, BAY-B5097)
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
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Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
Time Frame: 10-14 days after treatment (=visit 2)
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10-14 days after treatment (=visit 2)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
Time Frame: 6-8 weeks after treatment (=visit 3)
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6-8 weeks after treatment (=visit 3)
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Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
Time Frame: 10-14 days after treatment (=visit 2)
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10-14 days after treatment (=visit 2)
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Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
Time Frame: 6-8 weeks after treatment (=visit 3)
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6-8 weeks after treatment (=visit 3)
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Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
Time Frame: 10-14 days after treatment (=visit 2)
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10-14 days after treatment (=visit 2)
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Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
Time Frame: 6-8 weeks after treatment (=visit 3)
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6-8 weeks after treatment (=visit 3)
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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
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections and Mycoses
- Mycoses
- Vaginal Diseases
- Vulvar Diseases
- Vaginitis
- Vulvitis
- Vulvovaginitis
- Candidiasis
- Candidiasis, Vulvovaginal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Clotrimazole
- Miconazole
Other Study ID Numbers
- 13071
- 2008-000718-63 (EudraCT Number)
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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