A Phase IIb/III Study of Prof-001 for the Treatment of Patients With Recurrent Vulvovaginal Candidiasis (RVVC)

Inclusion Criteria: * Female patients ≥ 18 years * Patients suffering from an acute episode in RVVC, characterized by: * Positive vaginal smear (native or KOH) for budding yeasts and/or (pseudo-) hyphae, normal or intermediate flora * Two or more of the following signs and symptoms of VVC that are characterized as moderate or severe: itching, burning, irritation, edema, redness, or excoriation/fissure (Table 2). * At least 3 previous episodes of VVC during the last 12 months (i.e. at least 4 episodes including the current episode) * Readiness for sexual abstinence from start of treatment until test of cure (TOC) - visit * Ability to understand trial instructions and rating scales as well as ability to comply with treatment * Written informed consent Exclusion Criteria: * Known hypersensitivity to clotrimazole, diclofenac, fluconazole or any other ingredient of the investigational medicinal product * Pregnancy or breast feeding at time of screening (for all females of childbearing potential, negative pregnancy test at screening and monthly during active treatment period will be performed). Females in childbearing potential must use adequate contraception during the active treatment period (sexual abstinence is an accepted method of birth control) * Menstrual bleeding (spotting is not an exclusion criterion) during the first three days of treatment during the induction period * Acute cystitis diagnosed by anamnesis and urinary dip stick (positive for leukocytes and nitrites)…