NCT04807894 · Maimonides Medical Center
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
(PIVoT)
What this study is about
Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections.
View original scientific description
Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections. The role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown. The purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 60-90 yo Female
- Postmenopausal
- Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months).
- English Proficiency
- Unable or unwilling to use topical estrogen.
- Patients with history of or current endometrial or breast cancer and current aromatase inhibitor therapy may also be included in study.
- Patient on oral estrogen therapy may be included.
- Patient with slings, prior vaginal surgery or pessary may be included.
Exclusion criteria
- Current UTI/ Dipstick and culture positive (\> trace leukocytes or nitrites)
- Antibiotic (vaginal or oral) use in the last 4 weeks
- Current sexually transmitted infection
- Chronic Foley catheter use or chronic ureteral stent placement.
- Vaginal probiotic use in the last 4 weeks
- Patient currently using vaginal estrogen.
- Post-void Residual Volume \>150 mL or current diagnosis of urinary retention
- Non-evaluated hematuria (\> trace on dipstick, microscopic, gross)
- Unable to complete study tasks or comply with follow up.
Where
- Brooklyn, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 5, 2025 · Source of record for eligibility and locations