Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE4
60 participants
INTERVENTIONAL
2023-07-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Treatment group
Oxandrolone
Oxandrolone
oral oxandrolone for 12 weeks
Placebo Group
Placebo
Placebo
oral placebo for 12 weeks
Interventions
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Oxandrolone
oral oxandrolone for 12 weeks
Placebo
oral placebo for 12 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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George F. Hatch
OTHER
Responsible Party
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George F. Hatch
Associate Professor
Principal Investigators
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George Hatch, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Keck School of Medicine of the University of Southern California
Los Angeles, California, United States
Countries
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Other Identifiers
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HS-20-00161
Identifier Type: -
Identifier Source: org_study_id
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