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NCT06111209 · ClinicalTrials.gov registry record · Phase 2
The Anabolic Effect of Testosterone on Pelvic Floor Muscles
A Phase 2 study of Menopause and Stress Urinary Incontinence, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06111209: Recruiting Phase 2 study of Menopause and Stress Urinary Incontinence, sponsored by Brigham and Women's Hospital.
NCT06111209 is a Phase 2 study of Menopause and Stress Urinary Incontinence that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants, below the 9,394-participant average among 54 other Menopause trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06111209, a Phase 2 study of Menopause and Stress Urinary Incontinence, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Testosterone cypionate
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-02-15 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
What NCT06111209 shows while recruiting
NCT06111209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 9,394-participant average among 54 other Menopause trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Menopause appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06111209 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06111209 about?
NCT06111209 is a clinical study titled "The Anabolic Effect of Testosterone on Pelvic Floor Muscles". 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 st...
What is the current status of trial NCT06111209?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-02-15. Estimated completion is 2026-05-31.
What conditions does trial NCT06111209 study?
This clinical trial studies the following conditions: Menopause, Stress Urinary Incontinence.
What interventions are being tested in trial NCT06111209?
The interventions under investigation include: Placebo (DRUG), Testosterone cypionate (DRUG).
Who is sponsoring clinical trial NCT06111209?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06111209 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Menopause
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06111209's enrollment target sits among peer trials
30 41st of 54 higher than 11 of 54 other Menopause trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menopause trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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