Sex Hormone Supplementation and Rotator Cuff Repair

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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 will be randomly assigned to receive clomiphene citrate or placebo pills while healing from tendon repair surgery in their shoulder. Clomiphene increases sex hormone levels, and the investigators will test whether these increased sex hormone levels show promise in improving tendon healing, patient shoulder function and pain, and the quality of the bone in the upper arm bone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Clomiphene; Enclomiphene; Zuclomiphene

Criteria

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