CompletedPhase 2

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

Spain229 participantsStarted 2010-06

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Dose-response of Clinical and Mycological (Global) Therapeutic Response

Timeframe: day 26 ± 4 days

Trial details

NCT IDNCT01144286

SponsorFerrer Internacional S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-03

Results submitted2013-05-08

View on ClinicalTrials.gov More Vulvovaginal Candidiasis trials