The medical device It is indicated to promote the re-epithelialization processes of the vaginal mucosa, in the prevention of vaginal conditions of bacterial and fungal origin, and as an adjuvant in their treatment. The primary efficacy endpoint is based on the VAS symptom score (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score \<2) at the end of treatment.
Age range
18 Years – 75 Years
Sex
FEMALE
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
efficacy endpoint: VAS score for symptoms
Timeframe: "From enrollment to the end of treatment at 12 days (evaluation after menstrual cycle)
Ambrogio Frigerio, Medical doctor (gynecology)