Trial Condition(s):
Comparative efficacy of ovule vs tablet
13071
Not Available
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
- 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
- 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.
Locations | |
---|---|
Locations Frauenarztpraxis Dr. M. Baumgärtner München, Germany, 80333 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H. Frommeyer Osnabrück, Germany, 49074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Larbig Fulda, Germany, 36037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Clauss-Hoffmann Frankfurt, Germany, 65929 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. Johannes Brücker Dortmund, Germany, 44319 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. Adrian Flohr Krefeld, Germany, 47799 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moscow State Institute of Public Health Moscow, Russia, 119049 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Russian University of Peoples' Friendship Moscow, Russia, 117198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken und Polikliniken der Albert-Ludwigs-Universität Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. L. Baumgartner München, Germany, 85356 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Greven Hannover, Germany, 30459 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Peters Hamburg, Germany, 22159 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. T. Gent Hamburg, Germany, 22359 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis fr. Dr. G. Simko-Leonhard Wiesbaden, Germany, 65197 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moscow State Medical Stomatological University Moscow, Russia, 127473 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute State Federal Policlinic no 1 Moscow, Russia, 119002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Polyclinic N 3 of RF President Administrative Dept. Moscow, Russia, 129090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Russian State Medical University RSMU Moscow, Russia, 129090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Russian University of Peoples' Friendship Moscow, Russia, 117198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Russian State Medical University RSMU, Moscow, Hospital №31 Moscow, Russia, 129090 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
2