Comparative Efficacy of Ovule vs Tablet

NCT ID: NCT00755053

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 466 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-05-31

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)

Conditions

Clotrimazole; Ovulen; Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clotrimazole tablet (Canesten, BAY-B5097)

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

Group Type: ACTIVE_COMPARATOR

Clotrimazole, vaginal tablet

Intervention Type: DRUG

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

Clotrimazole ovule (Canesten, BAY-B5097)

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

Group Type: EXPERIMENTAL

Clotrimazole, vaginal ovule

Intervention Type: DRUG

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

Interventions

Clotrimazole, vaginal ovule

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

Intervention Type: DRUG

Clotrimazole, vaginal tablet

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Consumer Care Inc.

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Freiburg im Breisgau, Baden-Wurttemberg, Germany

München, Bavaria, Germany

München, Bavaria, Germany

Hamburg, City state of Hamburg, Germany

Hamburg, City state of Hamburg, Germany

Frankfurt am Main, Hesse, Germany

Fulda, Hesse, Germany

Wiesbaden, Hesse, Germany

Hanover, Lower Saxony, Germany

Osnabrück, Lower Saxony, Germany

Dortmund, North Rhine-Westphalia, Germany

Krefeld, North Rhine-Westphalia, Germany

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Countries

Germany; Russia

Related Links

http://www.clinicaltrialsregister.eu

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2008-000718-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13071

Identifier Type: -

Identifier Source: org_study_id