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

Phase 2

Completed

• Conditions: Vulvovaginal Candidiasis
• Interventions: Drug: arasertaconazole nitrate; Drug: placebo

• Registration Number: NCT01144286
• Lead Sponsor: Ferrer Internacional S.A.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2013-05-08
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-28
• Last Update Submitted: 2013-08-28
• Results First Posted: 2013-10-09
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 229

Inclusion Criteria

• Women aged between 18 to 65 years of age who have signed the informed consent.
• Not pregnant, not nursing.
• No indication of other vulvovaginitis or genital infections
• Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
• Negative wet mount results for T. vaginalis and clue cells.

Exclusion Criteria

• Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
• Hypersensitivity to imidazole products administered topically.
• Any other medical condition which in the opinion of the investigator could interfere with study conduct.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arasertaconazole nitrate 150 mg	arasertaconazole nitrate	Arasertaconazole nitrate 150 mg pessary, single dose
Arasertaconazole nitrate 150 mg	placebo	Arasertaconazole nitrate 150 mg pessary, single dose
arasertaconazole nitrate 300 mg	arasertaconazole nitrate	Arasertaconazole nitrate 300 mg pessary, single dose
arasertaconazole nitrate 300 mg	placebo	Arasertaconazole nitrate 300 mg pessary, single dose
arasertaconazole 600 mg	arasertaconazole nitrate	Arasertaconazole nitrate 600 mg pessary, single dose
arasertaconazole 600 mg	placebo	Arasertaconazole nitrate 600 mg pessary, single dose
placebo	arasertaconazole nitrate	placebo pessary, single dose

Primary Outcome Measures

Name	Time	Method
Dose-response of Clinical and Mycological (Global) Therapeutic Response	day 26 ± 4 days	Global therapeutic response at day 26± 4 days ("TOC"- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline "Vulvovaginal Candidiasis -Developing Antimicrobial Drugs for Treatment".

Secondary Outcome Measures

Name	Time	Method
Dose-response of Clinical and Mycological (Global)Therapeutic Response	Day 8 ± 2 days	Global therapeutic response at day 8± 2 days. Safety and tolerability.

Trial Locations

Locations (1)

Ferrer Internacional S.A.; 🇪🇸 Barcelona, Spain