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Clinical trial

Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo

ID
Name
702576
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.
Trial arms
Trial start
2020-11-01
Estimated PCD
2024-08-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Vaginal Placebo Cream Arm, Vaginal Testosterone Cream Arm
Other names:
Testosterone Cream
Size
100
Primary endpoint
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
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
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
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
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
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
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-10-23

1 organization

1 product

3 indications

Organization
Maimonides Medical Center
Product
Vaginal Cream
Indication
Urinary Tract Infection
Indication
Atrophic vaginitis
Indication
Postmenopausal Disorder