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Prospective Clinical Study, Using a Medical Device (RepHegyn) as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections
Sponsor: Innate srl
Summary
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.
Official title: Prospective Clinical Study, Using a Medical Device as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections: Evaluation of the Safety and Efficacy of Rephegyn Vaginal Ovules
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
34
Start Date
2026-03
Completion Date
2026-08
Last Updated
2026-01-26
Healthy Volunteers
No
Locations (1)
ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95
Garbagnate Milanese, Michigan, Italy