Status:
COMPLETED
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
Lead Sponsor:
Ferrer Internacional S.A.
Conditions:
Vulvovaginal Candidiasis
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT01144286
Start Date
June 1 2010
End Date
March 1 2011
Last Update
October 9 2013
Active Locations (1)
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1
Ferrer Internacional S.A.
Barcelona, Spain, 08028