Hormone therapy to improve healing after shoulder surgery
Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
PHASE2 · University of Utah · NCT04944836
This study tests if hormone therapy can help men with low hormone levels heal better after shoulder surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Male |
| Sponsor | University of Utah (other) |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT04944836 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of sex hormone therapy on healing after rotator cuff repair surgery in men with low hormone levels. Participants will be randomly assigned to receive either clomiphene citrate, which stimulates the body to produce testosterone and estrogen, or a placebo while recovering from surgery. The study aims to determine if increasing hormone levels can enhance tendon healing, reduce pain, and improve shoulder function. The research is based on the hypothesis that hormone deficiencies may contribute to both the occurrence of rotator cuff tears and the failure of surgical repairs.
Who should consider this trial
Good fit: Ideal candidates are men planning to undergo primary rotator cuff repair with a full thickness tear greater than 1 cm.
Not a fit: Patients with active infections, pre-operative testosterone supplementation, or certain medical conditions such as untreated prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing and function for patients recovering from rotator cuff surgery.
How similar studies have performed: While this approach is novel in the context of rotator cuff repair, previous studies have suggested that hormone therapy may have beneficial effects on tendon healing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salt Lake City, Utah
- University of Utah — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Study coordinator: Peter Chalmers
- Email: chalmerspractice@hsc.utah.edu
- Phone: 8015870063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tears