Actively Recruiting
Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo
Led by Maimonides Medical Center · Updated on 2025-11-05
100
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
M
Maimonides Medical Center
Lead Sponsor
A
American Urological Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether vaginal testosterone cream can reduce recurrent urinary tract infections (UTIs) in postmenopausal women aged 60 to 90 years. These women often face increased UTI risk due to hormonal changes affecting vaginal flora after menopause. The study also aims to understand how vaginal testosterone affects vaginal pH and flora compared to a placebo. Participants are randomly assigned to receive either vaginal testosterone cream or a placebo cream. Both treatments are applied once nightly for two weeks, followed by twice-weekly applications for eight months, totaling nine months of treatment. The testosterone cream is specially compounded and delivered using a calibrated vaginal applicator to ensure consistent dosing. Throughout the study, participants will have assessments at the start, at 4.5 months, and at 9 months. These include vaginal exams, swabs to analyze vaginal flora, vaginal pH measurements, and evaluations of vaginal atrophy. Researchers will monitor the frequency of UTIs and changes in vaginal health to compare the effects of testosterone cream versus placebo. The study is conducted under double-blind conditions to ensure unbiased results.
CONDITIONS
Brief Title
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 60 to 90 years
- Postmenopausal
- History of recurrent urinary tract infections (three or more culture-confirmed symptomatic UTIs in the past year or two or more in the past six months)
- Proficient in English
- Unable or unwilling to use topical estrogen
- May include patients with history or current endometrial or breast cancer on aromatase inhibitor therapy
- Patients on oral estrogen therapy may be included
- Patients with slings, prior vaginal surgery, or pessary may be included
You will not qualify if you...
- Current urinary tract infection confirmed by dipstick and culture
- Antibiotic (vaginal or oral) use within the last 4 weeks
- Current sexually transmitted infection
- Chronic Foley catheter use or chronic ureteral stent placement
- Vaginal probiotic use within the last 4 weeks
- Current use of vaginal estrogen
- Post-void residual urine volume greater than 150 mL or diagnosis of urinary retention
- Unexplained hematuria (positive on dipstick or microscopy)
- Unable to complete study tasks or comply with follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 months
Participants use vaginal testosterone or placebo cream once each night for two weeks followed by twice-weekly applications for a total of nine months.
3 visits (in-person) at initial, 4.5 months, and 9 months
Trial Site Locations
Total: 1 location
1
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
Research Team
A
Alison Polland, MD
M
Mariela Martinez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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