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Vaginal Testosterone for Recurrent UTIs in Postmenopausal Women

This study is looking at whether a vaginal testosterone cream can help prevent recurrent urinary tract infections (UTIs) in women aged 60-90 who have gone through menopause. Many postmenopausal women experience recurrent UTIs due to changes in vaginal health. The study will compare a vaginal cream containing testosterone propionate to a placebo (an inactive cream) to see if the testosterone cream is more effective. You may be eligible if you've had three or more UTIs in the past year or two in the last six months, and are unable or unwilling to use topical estrogen. The researchers will measure how often UTIs occur at 1, 4.5, and 9 months to see if the testosterone cream reduces their incidence.

Study design
This is a randomized, double-blind study, meaning participants will be randomly assigned to receive either the active cream or a placebo, and neither you nor your doctor will know which one you are receiving. The study plans to enroll 100 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess the effectiveness of the cream at 1 month, 4.5 months, and 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04807894

Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Recruiting
PHASE4Ages 60–90InterventionalTreatment
Maimonides Medical Center
~100 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:Vaginal Cream with Applicator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.
Measured over 1 month
+5 more outcomes measured

Conditions

Recurrent Urinary Tract Infection
Vaginal Atrophy
Postmenopausal Disorder

Explore related trials

Perimenopausal disorderRecurrent urinary tract infectionVaginal Atrophy

Where it's being run

1 sites across 1 states
New York1

Who to contact

Alison Polland, MD
[email protected]
(718) 283-7770
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.1 month

    Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 1 month to check for presence of UTI.

  • To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.4.5 months

    Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 4.5 months to check for presence of UTI.

  • To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.9 months

    Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 9 months to check for presence of UTI.

  • To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.1 month

    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 1 month to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  • To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.4.5 months

    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 4.5 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  • To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.9 months

    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 9 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.