NCT01144286

Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment

Multi-center, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study to Compare the Therapeutic Efficacy, Safety, and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate Pessaries in the Treatment of VVC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Ferrer Internacional S.A. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).

Conditions

• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	arasertaconazole nitrate	Arasertaconazole nitrate pessary, placebo pessary
DRUG	placebo	placebo, single dose

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-06-15
• Last updated: 2013-10-09
• Results posted: 2013-10-09

Locations

1 site across 1 country: Spain