Comparative Efficacy of Ovule vs Tablet

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

Official Title
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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

Conditions
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Clotrimazole, Ovulen, Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Clotrimazole, vaginal ovule
* Drug: Clotrimazole, vaginal tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clotrimazole, Ovule, Tablet, Vulvovaginal candidiasis, Non-inferiority