Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo

Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo (NCT04807894) is a Phase 4 interventional studying Recurrent Urinary Tract Infection and Vaginal Atrophy, sponsored by Maimonides Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Recurrent Urinary Tract Infection subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Vaginal Cream with Applicator

Vaginal testosterone 300-μg dose will be compounded with 13.5 mg of testosterone propionate in 0.45 mL of polysorbate National Formulary liquid and sufficient emollient cream base to make 45 g total. A calibrated vaginal applicator will be supplied to measure out doses of 1 g each. All study medications will be compounded by a single pharmacy so as to avoid variation in compounding between pharmacies and allow for control of compounding. Randomization will be conducted by the compounding pharmacy to allow for double-blinding of patients and clinicians.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Maimonides Medical Center

Brooklyn, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04807894), the sponsor (Maimonides Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04807894 clinical trial studying?

Who can participate in NCT04807894?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04807894?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04807894. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04807894. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.