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

Ferrer

Status and phase: Completed; Phase 2

Conditions: Vulvovaginal Candidiasis

Treatments: Drug: arasertaconazole nitrate; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01144286

2009-016655-21 (EudraCT Number)

P-090756-01

Details and patient eligibility

About

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).

Enrollment: 229 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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229 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo pessary, single dose

Treatment:

Drug: arasertaconazole nitrate

Arasertaconazole nitrate 150 mg

Experimental group

Description:

Arasertaconazole nitrate 150 mg pessary, single dose

Treatment:

Drug: arasertaconazole nitrate

Drug: placebo

arasertaconazole nitrate 300 mg

Experimental group

Description:

Arasertaconazole nitrate 300 mg pessary, single dose

Treatment:

Drug: arasertaconazole nitrate

Drug: placebo

arasertaconazole 600 mg

Experimental group

Description:

Arasertaconazole nitrate 600 mg pessary, single dose

Treatment:

Drug: arasertaconazole nitrate

Drug: placebo