NCT06111209 The Anabolic Effect of Testosterone on Pelvic Floor Muscles
| NCT ID | NCT06111209 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Stress Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-15 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-02-15 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Women, age 60 years and older. * Medically documented pure stress urinary incontinence on physical exam or urodynamic testing. * Normal mammogram within the last 12 months * Endometrial thickness of ≤4 mm in women with an intact uterus assessed by endometrial ultrasound. * Ability and willingness to provide informed consent. Exclusion Criteria: * • Medically documented urge or mixed urinary incontinence (stress and urge) on physical exam or urodynamic testing. * Participating in pelvic floor muscle training (PFMT) therapy currently or in the past 3 months * Previous pelvic surgery (i.e., hysterectomy, pelvic organ prolapse repair, mid-urethral sling placement, injection of urethral bulking agents) or radiation treatment to the pelvis. * History of ≥ Grade 3 pelvic organ prolapse * Neurologic disorder causing UI or bladder dysfunction (i.e., multiple sclerosis, Parkinson's disease, stroke, cerebral palsy, spinal cord injury) * Current urinary tract infection * History of breast or endometrial cancer * Use of systemic estrogen therapy in the past 3 months * Baseline hematocrit \>48%, serum creatinine \>2.5 mg/dL; HbA1c \>8.0%; BMI \>40 kg/m2 * Uncontrolled hypertension defined as an average of two blood pressure readings of greater than 160/100. * Subjects who are on insulin therapy will be excluded. * Uncontrolled congestive heart failure * Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 6 months * History of pulmonary embolism, deep vein thrombosis or a genetic thromboembolic disorder * History of bipolar disorder, schizophrenia or untreated major depression * Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing MRI
Contact & Investigator
Grace Huang, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06111209 clinical trial?
This trial is open to female participants only, aged 60 Years or older, studying Stress Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06111209 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06111209 currently recruiting?
Yes, NCT06111209 is actively recruiting participants. Contact the research team at sbhasin@bwh.harvard.edu for enrollment information.
Where is the NCT06111209 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06111209 clinical trial?
NCT06111209 is sponsored by Brigham and Women's Hospital. The principal investigator is Grace Huang, MD at Brigham and Women's Hospital. The trial plans to enroll 30 participants.