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

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144286
• Other study ID #: P-090756-01
• Secondary ID: 2009-016655-21
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2010
• Last updated: August 28, 2013
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: August 2013
• Source: Ferrer Internacional S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyHungary: Research Ethics Medical CommitteeLithuania: Bioethics CommitteeLithuania: State Medicine Control Agency - Ministry of HealthRussia: Ministry of Health of the Russian FederationRussia: FSI Scientific Center of Expertise of Medical ApplicationUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• arasertaconazole nitrate
Arasertaconazole nitrate pessary, placebo pessary
• placebo
placebo, single dose

Locations

Country	Name	City	State
Spain	Ferrer Internacional S.A.	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Ferrer Internacional S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-response of Clinical and Mycological (Global) Therapeutic Response	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".	day 26 ± 4 days	No
Secondary	Dose-response of Clinical and Mycological (Global)Therapeutic Response	Global therapeutic response at day 8± 2 days. Safety and tolerability.	Day 8 ± 2 days	No