Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:31 PM
Study NCT ID:
NCT05893069
Status:
SUSPENDED
Last Update Posted:
2025-05-21
First Post:
2023-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxandrolone Multiligament Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010074', 'term': 'Oxandrolone'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Randomized'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'FDA withdrew approval of the study product', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lean body mass', 'timeFrame': 'Change from baseline at 52 weeks', 'description': 'measured by bioelectrical impedance analysis'}, {'measure': 'body fat percentage', 'timeFrame': 'Change from baseline at 52 weeksf', 'description': 'measured by bioelectrical impedance analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxandrolone', 'Testosterone', 'Anabolic Steroid'], 'conditions': ['Ligament Tear Knee']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction\n\nExclusion Criteria:\n\n* Patients with prior ipsilateral knee surgery\n* Untreated diabetes mellitus\n* Pituitary tumor\n* Rheumatoid Arthritis\n* Uncontrolled hypertension\n* Congestive Heart Failure\n* Myocardial Infarction within the past 6 months\n* End-stage renal disease\n* Liver enzymes two times the normal value\n* DVT within the past 6 months\n* Disorder of the coagulation system\n* Currently taking anticoagulation\n* Prior or current use of anabolic steroids\n* Chromosomal disorders\n* Prostate cancer\n* Breast cancer\n* Hypercalcemia\n* Patients with COPD not responsive to bronchodilators\n* Patients with known liver disease\n* Patients at risk for liver tumors\n* Severe hyperlipidemia\n* Patients taking medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors, acetaminophen (Tylenol, others), cholesterol lowering'}, 'identificationModule': {'nctId': 'NCT05893069', 'briefTitle': 'Oxandrolone Multiligament Knee', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HS-20-00161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Oxandrolone', 'interventionNames': ['Drug: Oxandrolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oxandrolone', 'type': 'DRUG', 'description': 'oral oxandrolone for 12 weeks', 'armGroupLabels': ['Treatment group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral placebo for 12 weeks', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck School of Medicine of the University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'George Hatch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George F. Hatch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'George F. Hatch', 'investigatorAffiliation': 'University of Southern California'}}}}