Comparative Efficacy of Ovule vs Tablet

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Clotrimazole; Miconazole

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.