Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary T… (NCT07233473) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections
France50 participantsStarted 2025-10-20
Plain-language 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.
Who can participate
Age range18 Years – 84 Years
SexFEMALE
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Inclusion criteria
✓. Age: 18 to 84 years old.
✓. Sex: Female.
✓. Subject suffering from uncomplicated recurrent urinary tract infections: ≥ 4. UTIs within 12 months or ≥ 2 within 6 months.
✓. Subject having given freely and expressly her informed consent.
✓. Subject using a contraceptive regimen recognized as effective (pill, implant, Intra Uterine Device (IUD), condoms) since at least 12 weeks before inclusion visit and during the whole study. If subject use condoms as contraceptive regimen, a delay of 6 hours between application and sexual intercourse must be respected.
✓. Subject affiliated to a health social security system.
✓. Subject cooperative and aware of the device's modalities of use and the necessity and duration of the follow-up visits so that perfect adhesion to the protocol can be expected.
Exclusion criteria
✕. Pregnant or nursing woman or planning a pregnancy during the study.
What they're measuring
1
To evaluate the effectiveness of Multi-Gyn UT Protect gel for the prevention of Urinary Tract Infection (UTI) relapse within 4 months
. Subject who gave birth in the 3 previous months.
✕. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
✕. Subject in a social or sanitary establishment.
✕. Subject suspected to be non-compliant according to the investigator's judgment.
✕. Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
✕. Subject enrolled in another clinical trial or which exclusion period is not over.
✕. Subject with history of complicated urinary tract infection.