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

NCT07233473 | Recruiting

• 1 other identifier: 24-1775-U5
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of Multi-Gyn UT Protect gel for the prevention of Urinary Tract Infection (UTI) relapse within 4 months

  The number of patients without UTI relapse within 4 months will be summarized in frequency (N) and percentage (%), with a confidential interval CI 95%.

  4 months

Secondary Outcomes (1)

• To evaluate the effectiveness of Multi-Gyn UT Protect gel for the prevention of UTI relapse within 1, 2 and 3 months

  1, 2 and 3 months

Study Arms (1)

Study product

EXPERIMENTAL

Multi-Gyn UT Protect gel

Device: Multi-Gyn UT Protect gel

Interventions

Multi-Gyn UT Protect gel DEVICE

Vaginal gel

Study product

Eligibility Criteria

• Age: 18 Years - 84 Years
• Gender Eligibility Details: Women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• Pregnant or nursing woman or planning a pregnancy during the study.
• 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 with history of complicated urinary tract infection.
• Subject with vaginal mycosis infection in the last 3 weeks.
• Subject with recurrent vaginal mycosis (more than 2 in the last 6 months).
• Subject having a known allergy or hypersensitivity to one of the components of the investigational device.
• Subject suffering from a sexually transmitted gynaecological infection or aerobic vaginitis (including gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis).
• Subject with history of hormone-dependent cancer or bladder cancer.
• Subject with current genital malignancies.
• Subject using food supplements for prevention of urinary tract infection in the last 3 months.
• Subject using vaginal douches and who do not wish to refrain using them during the clinical investigation.

Sponsors & Collaborators

• Karo Pharma AB: lead

Study Sites (1)

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Diana Zeneli, MD

CONTACT

0031 614706949; diana.zeneli@karo.com

Harsha Madapura, Ph.D.

CONTACT

0046 72156 50 75; harsha.madapura@karo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Vaginal gel

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)