Actively Recruiting
Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections
Led by Karo Pharma AB · Updated on 2025-12-03
50
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 84 years old
- Female sex
- History of uncomplicated recurrent urinary tract infections with at least 4 UTIs in the last 12 months or at least 2 UTIs in the last 6 months
- Provided informed consent
- Using a recognized effective contraceptive method (pill, implant, IUD, condoms) for at least 12 weeks before inclusion and throughout the study; if using condoms, a 6-hour delay between gel application and intercourse is required
- Affiliated with a health social security system
- Cooperative and aware of the device use and follow-up requirements to ensure adherence to the protocol
You will not qualify if you...
- Pregnant, nursing, or planning pregnancy during the study
- Gave birth in the previous 3 months
- Deprived of freedom by legal or administrative decision or under guardianship
- Residing in social or sanitary establishments
- Suspected non-compliance by investigator judgment
- Received more than 6000 euros in clinical research indemnities in the last 12 months including this study
- Enrolled in another clinical trial or within exclusion period
- History of complicated urinary tract infection
- Current urinary tract infection at inclusion
- Vaginal mycosis infection in the last 3 weeks
- Recurrent vaginal mycosis (more than 2 episodes in last 6 months)
- Known allergy or hypersensitivity to any component of the investigational device
- Suffering from sexually transmitted gynecological infections or aerobic vaginitis
- History of hormone-dependent or bladder cancer
- Current genital malignancies
- Chemotherapy within 12 months before inclusion
- Radiotherapy in genito-urinary area within 12 months before inclusion
- Using treatment for urinary tract infection, vaginal conditions, or intravaginal treatments at inclusion
- Using food supplements for UTI prevention in last 3 months
- Using antibiotics, corticoids, or antifungal treatments in last 3 weeks
- Using vaginal douches and unwilling to stop during study
- Using a pessary
- Having a condition or medication that poses undue risk as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Eurofins Dermscan Pharmascan
Villeurbanne, France, 69100
Actively Recruiting
Research Team
D
Diana Zeneli, MD
CONTACT
H
Harsha Madapura, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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