Comparative Efficacy of Ovule vs Tablet

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00755053
First received: September 17, 2008
Last updated: May 29, 2013
Last verified: May 2013
  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)


Condition Intervention Phase
Clotrimazole
Ovulen
Vulvovaginal Candidiasis
Drug: Clotrimazole, vaginal ovule
Drug: Clotrimazole, vaginal tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Subjects with mycological and clinical cure [ Time Frame: 10-14 days after treatment (=visit 2) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subjects with mycological and clinical cure [ Time Frame: 6-8 weeks after treatment (=visit 3) ] [ Designated as safety issue: Yes ]
  • Clinical cure [ Time Frame: 10-14 days after treatment (=visit 2) ] [ Designated as safety issue: Yes ]
  • Clinical cure [ Time Frame: 6-8 weeks after treatment (=visit 3) ] [ Designated as safety issue: Yes ]
  • Mycological cure [ Time Frame: 10-14 days after treatment (=visit 2) ] [ Designated as safety issue: Yes ]
  • Mycological cure [ Time Frame: 6-8 weeks after treatment (=visit 3) ] [ Designated as safety issue: Yes ]

Enrollment: 466
Study Start Date: September 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Clotrimazole, vaginal ovule
1 dose of 500 mg Clotrimazole administered intravaginally as an ovule
Active Comparator: Arm 2 Drug: Clotrimazole, vaginal tablet
1 dose of 500 mg Clotrimazole administered intravaginally as a tablet

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755053

Locations
Germany
Freiburg, Baden-Württemberg, Germany, 79106
München, Bayern, Germany, 80333
München, Bayern, Germany, 85356
Frankfurt, Hessen, Germany, 65929
Fulda, Hessen, Germany, 36037
Wiesbaden, Hessen, Germany, 65197
Hannover, Niedersachsen, Germany, 30459
Osnabrück, Niedersachsen, Germany, 49074
Dortmund, Nordrhein-Westfalen, Germany, 44319
Krefeld, Nordrhein-Westfalen, Germany, 47799
Hamburg, Germany, 22159
Hamburg, Germany, 22359
Russian Federation
Moscow, Russian Federation, 119049
Moscow, Russian Federation, 129090
Moscow, Russian Federation, 117198
Moscow, Russian Federation, 127473
Moscow, Russian Federation, 119002
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT00755053     History of Changes
Other Study ID Numbers: 13071, 2008-000718-63
Study First Received: September 17, 2008
Last Updated: May 29, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation

Keywords provided by Bayer:
Clotrimazole
Ovule
Tablet
Vulvovaginal candidiasis
Non-inferiority

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Genital Diseases, Female
Mycoses
Vaginal Diseases
Vaginitis
Vulvar Diseases
Vulvitis
Vulvovaginitis

ClinicalTrials.gov processed this record on October 23, 2014