The Anabolic Effect of Testosterone on Pelvic Floor Muscles

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06111209
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Testosterone cypionate — DRUG
    weekly by intramuscular injection
  • Placebo — DRUG
    weekly by intramuscular injection

Study Details

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.

Key Dates

Start date
Feb 15, 2025
Status verified
May 2025
Primary completion
Mar 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Testosterone
    Testosterone Cypionate 25-mg weekly by intramuscular injection
  • Placebo Comparator: Placebo
    Placebo intramuscular injections weekly

Primary Outcome Measure

Change in pelvic floor muscle volume [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Shalender Bhasin, MB, BS
[email protected]
617-525-9150
Nancy Latham, PhD
[email protected]
6179999195
Shalender Bhasin, MB, BS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Menopause
By specialty
Women's healthFertility
By research site
Brigham and Women's Hospital· Boston, MA

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