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

Launched by EMS · Aug 26, 2021

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility 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.