Actively Recruiting

Phase 2
Age: 40Years - 80Years
MALE
NCT04944836

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

Led by University of Utah · Updated on 2026-03-19

58

Participants Needed

1

Research Sites

303 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • A plan for a primary rotator cuff repair surgery
  • Male sex
  • Rotator cuff tear greater than 1 cm in width, full thickness involving supraspinatus or infraspinatus tendon
Not Eligible

You will not qualify if you...

  • Active infection
  • Pre-operative testosterone supplementation
  • Known diagnosis of secondary testicular failure or testosterone deficiency
  • Medically unfit for surgery
  • Revision rotator cuff surgery
  • Unwillingness to participate or complete post-operative imaging
  • Inability to read or understand written instructions
  • Prisoner status
  • Concomitant patch augmentation or tendon transfer during surgery
  • Untreated prostate cancer
  • Liver disease
  • Pituitary or hypothalamic dysfunction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Utah

Salt Lake City, Utah, United States, 84108

Actively Recruiting

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Research Team

P

Peter Chalmers

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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