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

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