Clinical Trial

Prospective Clinical Study, Using a Medical Device (RepHegyn) as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections

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Record status
This record was last updated April 14, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-16.
Trial Details
NCT Number NCT07367295
Lead Sponsor Innate srl
Conditions Bacterial Infections, Treatment of Fungal Infections, Candidiasis
Enrollment 34 participants
Start Date 2026-05
Primary Completion 2026-05 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-14