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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.

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).

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Drug: arasertaconazole nitrate Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144286


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

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Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01144286     History of Changes
Other Study ID Numbers: P-090756-01
2009-016655-21 ( EudraCT Number )
First Posted: June 15, 2010    Key Record Dates
Results First Posted: October 9, 2013
Last Update Posted: October 9, 2013
Last Verified: August 2013
Keywords provided by Ferrer Internacional S.A.:
VVC
candidiasis
vaginal candidiasis
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases