check_circleStudy Completed

Clotrimazole, Ovulen, Vulvovaginal Candidiasis

Comparative efficacy of ovule vs tablet

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)

Key Participants Requirements

Sex

Female

Age

14 - 50 Years
  • - 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.

Trial summary

Enrollment Goal
466
Trial Dates
September 2008 - May 2009
Phase
Phase 3
Could I Receive a placebo
No
Products
Clotrimazole (BAYB5097)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Frauenarztpraxis Dr. M. BaumgärtnerMünchen, 80333, Germany
Completed
Praxis Hr. Dr. H. FrommeyerOsnabrück, 49074, Germany
Completed
Praxis Dr. LarbigFulda, 36037, Germany
Completed
Praxis Dr. S. Clauss-HoffmannFrankfurt, 65929, Germany
Completed
Praxis Hr. Dr. Johannes BrückerDortmund, 44319, Germany
Terminated
Praxis Hr. Dr. Adrian FlohrKrefeld, 47799, Germany
Completed
Moscow State Institute of Public HealthMoscow, 119049, Russia
Completed
Russian University of Peoples' FriendshipMoscow, 117198, Russia
Completed
Kliniken und Polikliniken der Albert-Ludwigs-UniversitätFreiburg, 79106, Germany
Completed
Praxis Hr. Dr. L. BaumgartnerMünchen, 85356, Germany
Completed
Praxis Hr. Dr. K. GrevenHannover, 30459, Germany
Completed
Praxis Hr. Dr. K. PetersHamburg, 22159, Germany
Completed
Praxis Hr. Dr. T. GentHamburg, 22359, Germany
Completed
Praxis fr. Dr. G. Simko-LeonhardWiesbaden, 65197, Germany
Completed
Moscow State Medical Stomatological UniversityMoscow, 127473, Russia
Completed
Institute State Federal Policlinic no 1Moscow, 119002, Russia
Completed
Polyclinic N 3 of RF President Administrative Dept.Moscow, 129090, Russia
Completed
Russian State Medical University RSMUMoscow, 129090, Russia
Terminated
Russian University of Peoples' FriendshipMoscow, 117198, Russia
Completed
Russian State Medical University RSMU, Moscow, Hospital №31Moscow, 129090, Russia

Primary Outcome

  • Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
    date_rangeTime Frame:
    10-14 days after treatment (=visit 2)

Secondary Outcome

  • Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
    date_rangeTime Frame:
    6-8 weeks after treatment (=visit 3)
  • Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
    date_rangeTime Frame:
    10-14 days after treatment (=visit 2)
  • Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
    date_rangeTime Frame:
    6-8 weeks after treatment (=visit 3)
  • Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
    date_rangeTime Frame:
    10-14 days after treatment (=visit 2)
  • Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
    date_rangeTime Frame:
    6-8 weeks after treatment (=visit 3)

Trial design

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