Status:
COMPLETED
Comparative Efficacy of Ovule vs Tablet
Lead Sponsor:
Bayer
Conditions:
Clotrimazole
Ovulen
Eligibility:
FEMALE
14-50 years
Phase:
PHASE3
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)
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT00755053
Start Date
September 1 2008
End Date
May 1 2009
Last Update
August 6 2015
Active Locations (17)
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1
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
München, Bavaria, Germany, 80333
3
München, Bavaria, Germany, 85356
4
Hamburg, Hamburg, Germany, 22159