This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* scheduled for rotator cuff repair
* failed nonoperative management of chronic, full thickness rotator cuff tears
* full thickness rotator cuff tear confirmed on MRI
Exclusion Criteria:
* patients with prior shoulder surgery or prior rotator cuff repair
* tears larger than 5 cm
* significant glenohumeral arthritis (Hamada Grade 2 or higher)
* Untreated diabetes mellitus
* Pituitary tumor
* Rheumatoid arthritis
* Uncontrolled hypertension
* Congestive heart failure
* Myocardial infarction within the past 6 months
* End-stage renal disease
* Liver enzymes two times the normal value
* Deep Vein Thrombosis (DVT) within the past 6 months
* Disorder of the coagulation system
* Currently taking anticoagulation
* Claustrophobia
* Prior or current use of anabolic steroids
* Chromosomal disorders
* Prostate cancer
* Breast cancer
* Hypercalcemia
* Medications that interfere with testosterone production or function, including but not limited to 5 alpha-reductase inhibitors
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 6 weeks after the last dose of study treatment
* Any other condition or treatment interfering with completion of the trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in structural integrity of the rotator cuff/tendon healing