drugset / Trial / NCT06111209

The Anabolic Effect of Testosterone on Pelvic Floor Muscles

NCT06111209

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Stress urinary incontinence is the most common female pelvic floor disorder encountered in clinical practice with significant negative impact on quality of life. The prevalence of urinary incontinence increases with aging, and weakness of the pelvic floor muscles contributes to the development of stress urinary incontinence. Given that androgen receptors are expressed throughout the pelvic floor, the anabolic effects of androgens on pelvic floor muscles may provide a therapeutic option in women with stress urinary incontinence. The investigators are conducting a randomized, double-blind, placebo-controlled proof-of-concept trial in older postmenopausal women with stress urinary incontinence to assess whether testosterone therapy can increase pelvic floor muscles and improve urinary function.

Timeline

Start
2025-02-15
Primary completion
2026-12-31
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Testosterone Cypionate Small molecule 25 mg Intramuscular