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Could a hormone patch boost shoulder surgery recovery?

NCT ID NCT06318403

Disease control Sponsor: University of Utah 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether estradiol patches can improve shoulder healing after rotator cuff repair in post-menopausal women. About 58 women will receive either an estradiol patch or a placebo patch for three months after surgery. The goal is to see if the hormone helps reduce pain, improve strength, and restore shoulder function better than surgery alone.

What this could mean

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

Active substance
estradiol (a form of estrogen) given as a skin patch
What this could lead to
If it works, this could point toward a simple hormone treatment to improve recovery and reduce pain after rotator cuff surgery in post-menopausal women.
What could go wrong
This is a very small, early-phase trial with only 58 participants. The results may not apply to all women, and the hormone patch could have side effects like skin irritation or hormone-related risks.

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 58 people

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

Expected to start

Mar 2028

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

50 to 80 years

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 1. A plan for a primary rotator cuff repair 2. Female sex (assigned sex at birth) 3. \>1 cm tear width, full thickness supraspinatus/infraspinatus tear 4. Post-menopausal, as defined by at least twelve months since last menses 5. Age 50-80 Exclusion Criteria 1. Active infection 2. Baseline serum estradiol \>20 pg/mL 3. Infraspinatus or supraspinatus muscle atrophy of greater than or equal to Goutallier grade 3 4. Pre-operative systemic estradiol supplementation 5. Medically unfit for operative intervention 6. Revision surgery 7. Unwillingness to participate in the study, including post-operative imaging 8. Inability to read or comprehend written instructions 9. Prisoner 10. Concomitant patch augmentation or tendon-transfer 11. Breast cancer or a history of breast cancer or other estradiol-dependent neoplasia 12. Liver disease as documented in the medical record 13. Active venous thromboembolic disease, such as deep venous thrombosis, pulmonary embolism, a history of these conditions, or a known predisposition to these disorders (such as Protein C, protein S, or antithrombin deficiency) 14. Active arterial thromboembolic disease, such as stroke, myocardiac infarction, a history of these conditions, or a known predisposition to these disorders 15. Isolated subscapularis tears 16. Known anaphylactic reaction or hypersensitivity to estradiol, adhesive, or transdermal patches

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

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

Menopause Menopause related conditions Rotator cuff injuries Rotator cuff syndrome Rotator cuff tears

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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