NCT04944836 Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
| NCT ID | NCT04944836 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Rotator Cuff Tears |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 58 participants in total. It began in 2023-03-09 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04944836 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 80 Years, studying Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04944836 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04944836 currently recruiting?
Yes, NCT04944836 is actively recruiting participants. Contact the research team at chalmerspractice@hsc.utah.edu for enrollment information.
Where is the NCT04944836 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT04944836 clinical trial?
NCT04944836 is sponsored by University of Utah. The trial plans to enroll 58 participants.