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

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ClinicalTrials.gov Identifier: NCT01144286
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : October 9, 2013
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.

Tracking Information
First Submitted Date  ICMJE June 9, 2010
First Posted Date  ICMJE June 15, 2010
Results First Submitted Date  ICMJE May 8, 2013
Results First Posted Date  ICMJE October 9, 2013
Last Update Posted Date October 9, 2013
Study Start Date  ICMJE June 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
Dose-response of Clinical and Mycological (Global) Therapeutic Response [ Time Frame: 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".
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
Dose-response of Clinical and Mycological (Global) Therapeutic Response [ Time Frame: day 26 ± 4 days ]
Global therapeutic response at day 26± 4 days.
Change History Complete list of historical versions of study NCT01144286 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
Dose-response of Clinical and Mycological (Global)Therapeutic Response [ Time Frame: Day 8 ± 2 days ]
Global therapeutic response at day 8± 2 days. Safety and tolerability.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vulvovaginal Candidiasis
Intervention  ICMJE
  • Drug: arasertaconazole nitrate
    Arasertaconazole nitrate pessary, placebo pessary
  • Drug: placebo
    placebo, single dose
Study Arms  ICMJE
  • Placebo Comparator: placebo
    placebo pessary, single dose
    Intervention: Drug: arasertaconazole nitrate
  • Experimental: Arasertaconazole nitrate 150 mg
    Arasertaconazole nitrate 150 mg pessary, single dose
    Interventions:
    • Drug: arasertaconazole nitrate
    • Drug: placebo
  • Experimental: arasertaconazole nitrate 300 mg
    Arasertaconazole nitrate 300 mg pessary, single dose
    Interventions:
    • Drug: arasertaconazole nitrate
    • Drug: placebo
  • Experimental: arasertaconazole 600 mg
    Arasertaconazole nitrate 600 mg pessary, single dose
    Interventions:
    • Drug: arasertaconazole nitrate
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2013)
229
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2010)
225
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01144286
Other Study ID Numbers  ICMJE P-090756-01
2009-016655-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferrer Internacional S.A.
Study Sponsor  ICMJE Ferrer Internacional S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ferrer Internacional S.A.
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP