NCT07233473

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

Prospective, Multicentric, Single Arm Clinical Investigation to Assess the Effectiveness and Safety of Multi-Gyn UT Protect Gel for Prevention of Recurrent Urinary Tract Infections

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Karo Pharma AB · Industry
• Sex: Female
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

Summary

Urinary Tract Infections (UTIs) are among the most common bacterial infections. Although they are typically treated effectively with antibiotics, recurrence is a frequent and troublesome issue. This clinical trial aims to evaluate the safety and effectiveness of Multi-Gyn UT Protect gel in preventing the recurrence of UTIs. The trial will involve 50 adult female participants who have experienced a UTI in recent months but do not currently have an active infection. Each participant will apply the gel twice a week for four months. They will be monitored throughout this period to assess whether participants develop the reappearance of UTI symptoms. The primary objective is to determine how many participants do not experience a recurrence of UTI by the end of the four-month treatment period.

Conditions

• Urinary Tract Infections (UTIs)

Interventions

Type	Name	Description
DEVICE	Multi-Gyn UT Protect gel	Vaginal gel

Timeline

• Start date: 2025-10-20
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2025-11-18
• Last updated: 2025-12-03

Locations

1 site across 1 country: France