NCT07367295

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 34 (estimated)
• Sponsor: Innate srl · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Infections
• Treatment of Fungal Infections, Candidiasis

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2026-01-26
• Last updated: 2026-04-14

Locations

1 site across 1 country: Italy