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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
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 466 |
| Start date | 2008-09 |
| Completion | 2009-05 |
Conditions
- Clotrimazole
- Ovulen
- Vulvovaginal Candidiasis
Interventions
- Clotrimazole, vaginal ovule
- Clotrimazole, vaginal tablet
Primary outcomes
- Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14) — 10-14 days after treatment (=visit 2)
Countries
Germany, Russia