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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Butoconazole

Criteria

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.