SuspendedPhase 4

Oxandrolone Multiligament Knee

Stopped: FDA withdrew approval of the study product

United States60 participantsStarted 2023-07-01

Plain-language summary

This study is about healing after a rmultiligament knee reconstruction 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 is effective in aiding in the healing process and restoring muscle mass.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: • Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction Exclusion Criteria: * Patients with prior ipsilateral knee surgery * 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 * DVT within the past 6 months * Disorder of the coagulation system * Currently taking anticoagulation * Prior or current use of anabolic steroids * Chromosomal disorders * Prostate cancer * Breast cancer * Hypercalcemia * Patients with COPD not responsive to bronchodilators * Patients with known liver disease * Patients at risk for liver tumors * Severe hyperlipidemia * Patients taking medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors, acetaminophen (Tylenol, others), cholesterol lowering

What they're measuring

lean body mass

Timeframe: Change from baseline at 52 weeks

body fat percentage

Timeframe: Change from baseline at 52 weeksf

Trial details

NCT IDNCT05893069

SponsorGeorge F. Hatch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31