Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age60-90
SponsorMaimonides Medical Center
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Vaginal Cream with Applicator
DrugVaginal 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Vaginal Testosterone Cream ArmExperimental treatment 1 intervention
Group B: Vaginal Placebo Cream ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
1 month2
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.
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.
Time frame
4.5 months3
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.
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.
Time frame
9 months4
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.
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.
Time frame
1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maimonides Medical Center
Lead sponsor
American Urological Association
Collaborator
Source ClinicalTrials.gov