Oxandrolone Rotator Cuff Trial
Stopped early · Not applicable · Has a placebo group
Conditions studied: Rotator Cuff Tear
In brief
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.
Key facts
- Study ID
- NCT03091075
- Run by
- University of Southern California
- People needed
- 4
- Starts
- 2018-09-23
- Expected to finish
- 2026-01-06
- Last updated by the study team
- 2026-05-07
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- scheduled for rotator cuff repair
- failed nonoperative management of chronic, full thickness rotator cuff tears
- full thickness rotator cuff tear confirmed on MRI
You may not qualify if…
- 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
Where it is running
- Keck School of Medicine of the University of Southern California — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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