Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 1, 2020

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2025

Conditions
Recurrent Urinary Tract InfectionVaginal AtrophyPostmenopausal Disorder
Interventions
DRUG

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.

Trial Locations (1)

11219

RECRUITING

Maimonides Medical Center, Brooklyn

Sponsors
All Listed Sponsors
collaborator

American Urological Association

OTHER

lead

Maimonides Medical Center

OTHER

NCT04807894 - Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo | Biotech Hunter | Biotech Hunter