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Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections
Sponsor: Karo Pharma AB
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-10-20
Completion Date
2027-03-31
Last Updated
2025-12-03
Healthy Volunteers
Yes
Conditions
Interventions
Multi-Gyn UT Protect gel
Vaginal gel
Locations (1)
Eurofins Dermscan Pharmascan
Villeurbanne, France