Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.

National, Multicenter, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis

The purpose of this study is to evaluate the efficacy and safety of different doses of Venus association in the treatment of vulvovaginal candidiasis.

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Age greater than or equal to 18 years;
• Female participants, post-menarche;
• Clinical diagnosis of vulvovaginal candidiasis, defined as white, fluid or creamy vaginal discharge, in addition to the following findings:
• Itching and one or more of the following signs and symptoms characterized as moderate or severe: vulvar/vaginal erythema, edema, burning, irritation, and excoriation;
• Normal vaginal pH;
• Preparation of KOH or saline from a sample taken from inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or growing yeast.

Exclusion Criteria:

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Participation in a clinical trial in the year prior to this study;
• Pregnancy or risk of pregnancy and lactating patients;
• Known hypersensitivity to any of the formula compounds;
• Virgin participants;
• Postmenopausal participants or with vaginal atrophy;
• Participants with other vaginal infections;
• Participants with recurrent vulvovaginal candidiasis;
• Participants using immunosuppressive drugs;
• Participants diagnosed with serious systemic diseases.