NCT04807894 Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
| NCT ID | NCT04807894 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Maimonides Medical Center |
| Condition | Recurrent Urinary Tract Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2020-11-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04807894 clinical trial?
This trial is open to female participants only, aged 60 Years or older, up to 90 Years, studying Recurrent Urinary Tract Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04807894 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04807894 currently recruiting?
Yes, NCT04807894 is actively recruiting participants. Contact the research team at apolland@maimonidesmed.org for enrollment information.
Where is the NCT04807894 trial being conducted?
This trial is being conducted at Brooklyn, United States.
Who is sponsoring the NCT04807894 clinical trial?
NCT04807894 is sponsored by Maimonides Medical Center. The trial plans to enroll 100 participants.