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Testosterone shots aim to strengthen pelvic floor in older women

NCT ID NCT06111209

Symptom relief Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether weekly testosterone injections can increase pelvic floor muscle size and improve stress urinary incontinence in women aged 60 and older. The trial involves 30 participants and uses MRI to measure muscle changes. It is a small, early-stage proof-of-concept study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
testosterone cypionate
What this could lead to
If it works, this could point toward a new treatment for stress urinary incontinence in older women by strengthening pelvic floor muscles.
What could go wrong
This is a very small pilot study with only 30 participants, so results may not apply to everyone. It is also early-stage, and the primary outcome is muscle volume, not direct symptom improvement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

female stress incontinence Pelvic Floor Disorders Urinary Incontinence, Stress

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Menopause Stress urinary incontinence

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.