Recruiting

Vaginal TestosteronePrevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Sponsor:

Maimonides Medical Center

Code:

NCT04807894

Conditions

Recurrent Urinary Tract Infection

Vaginal Atrophy

Postmenopausal Disorder

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Vaginal Cream with Applicator

Study Details

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.

Conditions

Recurrent Urinary Tract Infection

Vaginal Atrophy

Postmenopausal Disorder

Study ID

NCT04807894

Start date

Nov 1, 2020

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vaginal Testosterone Cream Arm

Women enrolled in this arm will receive vaginal testosterone cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.

placebo comparator: Vaginal Placebo Cream Arm

Women enrolled in this arm will receive vaginal placebo cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.

Interventions

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.

Primary outcome measure

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. [ Time Frame: 1 month ]
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. [ Time Frame: 4.5 months ]
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. [ Time Frame: 9 months ]
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. [ Time Frame: 1 month ]
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. [ Time Frame: 4.5 months ]
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. [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Alison Polland, MD

(718) 283-7770 apolland@maimonidesmed.org

Mariela Martinez, MD

mmrivera@maimonidesmed.org

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Alison Polland, MD

718-283-7770 apolland@maimonidesmed.org

Principal Investigator:

Alison Polland, MD

More Information

Sponsor

Maimonides Medical Center

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

urinary tract infections,
postmenopausal women
vaginal atrophy,
vaginal flora

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maimonides Medical Center on 2025-11-05.