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

RecruitingPhase 2Ages 40 Years - 80 YearsMaleUniversity of Utah
NCT04944836 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria 1. A plan for a primary rotator cuff repair 2. Male sex 3. \>1 cm tear width, full thickness supraspinatus/infraspinatus tear Exclusion Criteria 1. Active infection 2. Pre-operative testosterone supplementation 3. Known diagnosis of secondary testicular failure or testosterone deficiency 4. Medically unfit for operative intervention 5. Revision surgery 6. Unwillingness to participate in the study, including post-operative imaging 7. Inability to read or comprehend written instructions 8. Prisoner 9. Concomitant patch augmentation or tendon-transfer 10. Untreated prostate cancer 11. Liver disease 12. Pituitary or hypothalamic dysfunction
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What it tests

  • Clomiphene Citrate
  • Rotator Cuff Repair
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Where

1 site
University of Utah
Salt Lake City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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