Comparative Efficacy of Ovule vs Tablet

Phase 3

Completed

• Conditions: Clotrimazole; Ovulen; Vulvovaginal Candidiasis
• Interventions: Drug: Clotrimazole, vaginal tablet; Drug: Clotrimazole, vaginal ovule

• Registration Number: NCT00755053
• Lead Sponsor: Bayer

Brief 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)

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 466

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clotrimazole tablet (Canesten, BAY-B5097)	Clotrimazole, vaginal tablet	Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Clotrimazole ovule (Canesten, BAY-B5097)	Clotrimazole, vaginal ovule	Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)	10-14 days after treatment (=visit 2)

Secondary Outcome Measures

Name	Time	Method
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 Mycological 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 Clinical Cure at Visit 3 (Week 6 to 8)	6-8 weeks after treatment (=visit 3)