Trial Condition(s):

Clotrimazole, Ovulen, Vulvovaginal Candidiasis

Comparative efficacy of ovule vs tablet

Bayer Identifier:

13071

ClinicalTrials.gov Identifier:

NCT00755053

EudraCT Number:

2008-000718-63

Study Completed

Trial Purpose

The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)

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.

Trial Summary

Enrollment Goal
466
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Clotrimazole (BAYB5097)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Frauenarztpraxis Dr. M. Baumgärtner

München, Germany, 80333

Status
Completed
 
Locations

Praxis Hr. Dr. H. Frommeyer

Osnabrück, Germany, 49074

Status
Completed
 
Locations

Praxis Dr. Larbig

Fulda, Germany, 36037

Status
Completed
 
Locations

Praxis Dr. S. Clauss-Hoffmann

Frankfurt, Germany, 65929

Status
Completed
 
Locations

Praxis Hr. Dr. Johannes Brücker

Dortmund, Germany, 44319

Status
Completed
 
Locations

Praxis Hr. Dr. Adrian Flohr

Krefeld, Germany, 47799

Status
Terminated
 
Locations

Moscow State Institute of Public Health

Moscow, Russia, 119049

Status
Completed
 
Locations

Russian University of Peoples' Friendship

Moscow, Russia, 117198

Status
Completed
 
Locations

Kliniken und Polikliniken der Albert-Ludwigs-Universität

Freiburg, Germany, 79106

Status
Completed
 
Locations

Praxis Hr. Dr. L. Baumgartner

München, Germany, 85356

Status
Completed
 
Locations

Praxis Hr. Dr. K. Greven

Hannover, Germany, 30459

Status
Completed
 
Locations

Praxis Hr. Dr. K. Peters

Hamburg, Germany, 22159

Status
Completed
 
Locations

Praxis Hr. Dr. T. Gent

Hamburg, Germany, 22359

Status
Completed
 
Locations

Praxis fr. Dr. G. Simko-Leonhard

Wiesbaden, Germany, 65197

Status
Completed
 
Locations

Moscow State Medical Stomatological University

Moscow, Russia, 127473

Status
Completed
 
Locations

Institute State Federal Policlinic no 1

Moscow, Russia, 119002

Status
Completed
 
Locations

Polyclinic N 3 of RF President Administrative Dept.

Moscow, Russia, 129090

Status
Completed
 
Locations

Russian State Medical University RSMU

Moscow, Russia, 129090

Status
Completed
 
Locations

Russian University of Peoples' Friendship

Moscow, Russia, 117198

Status
Terminated
 
Locations

Russian State Medical University RSMU, Moscow, Hospital №31

Moscow, Russia, 129090

Status
Completed
 

Trial Design