Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Rotator Cuff Tears

In brief

Shoulder tendon tears are a common cause of shoulder pain and disability and after surgery the repaired tendon often does not heal. In this pilot study, men with low sex hormone levels will be randomly assigned to receive sex hormone therapy or placebo pills while healing from tendon repair surgery in their shoulder. Sex hormone therapy increases sex hormone levels, and the investigators will test whether these increased sex hormone levels show promise in improving tendon healing and patient shoulder function and pain.

Key facts

Study ID

NCT04944836

Run by

University of Utah

People needed

58

Starts

2023-03-09

Expected to finish

2029-01-01

Last updated by the study team

2026-03-19

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• A plan for a primary rotator cuff repair
• Male sex
• >1 cm tear width, full thickness supraspinatus/infraspinatus tear

You may not qualify if…

• Active infection
• Pre-operative testosterone supplementation
• Known diagnosis of secondary testicular failure or testosterone deficiency
• Medically unfit for operative intervention
• Revision surgery
• Unwillingness to participate in the study, including post-operative imaging
• Inability to read or comprehend written instructions
• Prisoner
• Concomitant patch augmentation or tendon-transfer
• Untreated prostate cancer
• Liver disease
• Pituitary or hypothalamic dysfunction

Where it is running

• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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