Home › Rotator Cuff Injuries › NCT04944836

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

Who can join

Ages 40 to 80 · Men

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

About the study

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.

What is being tested

• Clomiphene Citrate (drug)
• Rotator Cuff Repair (procedure)

Sponsor: University of Utah · Participants: 58 · Started: Mar 9, 2023

Contact the study team

• Peter Chalmers · Phone: 8015870063

Official record on ClinicalTrials.gov — NCT04944836

Locations in the U.S.

Conditions

• Rotator Cuff Injuries

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.