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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01144286
First received: June 9, 2010
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Vulvovaginal Candidiasis
Drug: arasertaconazole nitrate
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:
  • Dose-response of Clinical and Mycological (Global) Therapeutic Response [ Time Frame: day 26 ± 4 days ] [ Designated as safety issue: No ]
    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:
  • Dose-response of Clinical and Mycological (Global)Therapeutic Response [ Time Frame: Day 8 ± 2 days ] [ Designated as safety issue: No ]
    Global therapeutic response at day 8± 2 days. Safety and tolerability.


Enrollment: 229
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo pessary, single dose
Drug: arasertaconazole nitrate
Arasertaconazole nitrate pessary, placebo pessary
Experimental: Arasertaconazole nitrate 150 mg
Arasertaconazole nitrate 150 mg pessary, single dose
Drug: arasertaconazole nitrate
Arasertaconazole nitrate pessary, placebo pessary
Drug: placebo
placebo, single dose
Experimental: arasertaconazole nitrate 300 mg
Arasertaconazole nitrate 300 mg pessary, single dose
Drug: arasertaconazole nitrate
Arasertaconazole nitrate pessary, placebo pessary
Drug: placebo
placebo, single dose
Experimental: arasertaconazole 600 mg
Arasertaconazole nitrate 600 mg pessary, single dose
Drug: arasertaconazole nitrate
Arasertaconazole nitrate pessary, placebo pessary
Drug: placebo
placebo, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144286

Locations
Spain
Ferrer Internacional S.A.
Barcelona, Spain, 08028
Sponsors and Collaborators
Ferrer Internacional S.A.
  More Information

No publications provided

Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01144286     History of Changes
Other Study ID Numbers: P-090756-01, 2009-016655-21
Study First Received: June 9, 2010
Results First Received: May 8, 2013
Last Updated: August 28, 2013
Health Authority: Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Hungary: Research Ethics Medical Committee
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Ferrer Internacional S.A.:
VVC
candidiasis
vaginal candidiasis

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Genital Diseases, Female
Mycoses
Vaginal Diseases
Vaginitis
Vulvar Diseases
Vulvitis
Vulvovaginitis

ClinicalTrials.gov processed this record on October 23, 2014