Oxandrolone Multiligament Knee

Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial

Status

Suspended

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05893069

Enrollment

Registered

2023-06-07

Start date

2023-07-01

Completion date

2027-12-31

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ligament Tear Knee

Keywords

Oxandrolone, Testosterone, Anabolic Steroid

Brief 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.

Interventions

DRUGOxandrolone

oral oxandrolone for 12 weeks

DRUGPlacebo

oral placebo for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Randomized

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
lean body mass	Change from baseline at 52 weeks	measured by bioelectrical impedance analysis
body fat percentage	Change from baseline at 52 weeksf	measured by bioelectrical impedance analysis

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGeorge Hatch, MD

University of Southern California

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026