NCT00755053

Comparative Efficacy of Ovule vs Tablet

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 466 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 14 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Clotrimazole
• Ovulen
• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Clotrimazole, vaginal ovule	Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
DRUG	Clotrimazole, vaginal tablet	Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-09-18
• Last updated: 2015-08-06

Locations

17 sites across 2 countries: Germany, Russia