Ligament Tear KneePhase 4NCT05893069
Oxandrolone Multiligament Knee
A Phase 4 study testing Oxandrolone in people with Ligament Tear Knee, run by George F. Hatch at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ligament Tear Knee
- What is being tested?
- Oxandrolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction
Who cannot join
- Patients with prior ipsilateral knee surgery
- Untreated diabetes mellitus
- Pituitary tumor
- Rheumatoid Arthritis
- Uncontrolled hypertension
- Congestive Heart Failure
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033
About this study
Official title: Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial
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.
- Conditions
- Ligament Tear Knee
- Being tested
- Oxandrolone, Placebo
- Keywords
- Oxandrolone, Testosterone, Anabolic Steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxandroloneDrug
oral oxandrolone for 12 weeks
PlaceboDrug
oral placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Oxandrolone Receives: Drug: Oxandrolone |
| Placebo Group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean body mass
measured by bioelectrical impedance analysis
Measured: Change from baseline at 52 weeks
body fat percentage
measured by bioelectrical impedance analysis
Measured: Change from baseline at 52 weeksf
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: FDA withdrew approval of the study product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament Tear KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George F. Hatch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, George F. Hatch, University of Southern California
- Investigators
- George Hatch, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893069
- Sponsor's protocol ID
- HS-20-00161
- Status last verified
- Mar 2026
- First submitted
- 16 May 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05893069
- Acronym / sponsor ID
- HS-20-00161
- Conditions
- Ligament Tear Knee
- Keywords
- Oxandrolone, Testosterone, Anabolic Steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: FDA withdrew approval of the study product
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- George F. HatchUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: OxandroloneOxandrolone |
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction
Key exclusion criteria (22 listed)
- Patients with prior ipsilateral knee surgery
- Untreated diabetes mellitus
- Pituitary tumor
- Rheumatoid Arthritis
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxandroloneoral oxandrolone for 12 weeks | Drug | Treatment group |
| Placebooral placebo for 12 weeks | Drug | Placebo Group |
Primary outcome
lean body mass
Time frame: Change from baseline at 52 weeks
measured by bioelectrical impedance analysis
body fat percentage
Time frame: Change from baseline at 52 weeksf
measured by bioelectrical impedance analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Hatch, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxandrolone in people with Ligament Tear Knee, run by George F. Hatch at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lean body mass (time frame: Change from baseline at 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.