Status:
UNKNOWN
Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
Lead Sponsor:
The Stone Research Foundation for Sports Medicine and Arthritis
Conditions:
Muscle Atrophy
Surgery
Eligibility:
MALE
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in patient's ability to return to activities. Although the use of testosterone in aging and chronic muscle loss has...
Detailed Description
This is an in vivo study using serial IM testosterone undeconate injections in participants undergoing knee surgery with limited weight bearing post-operatively which includes partial/total knee repla...
Eligibility Criteria
Inclusion
- Males age 18-65.
- Undergoing significant knee surgery such as partial/total knee replacement, ligament reconstruction, meniscus surgeries or articular cartilage paste grafting.
Exclusion
- Men with carcinoma of the breast or known or suspected carcinoma of the prostate.
- Men with BMI \> 30 and Type I or II diabetes diagnosis
- Men prone to deep vein thrombosis or sleep apnea.
- Men with pre-existing hematocrit abnormalities.
- Men with pre-existing cardiac, renal, hepatic disease.
- Men who are taking insulin, medicines that decrease blood clotting or corticosteroids.
- Men with known hypersensitivity to testosterone undecanoate or any of its formulation ingredients (testosterone, refined castor oil, benzyl benzoate).
- Subject's unable or unwilling to comply with the protocol.
- Subject's unable to provide informed consent.
- Subject's unable to understand verbal and/or written English.
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04456530
Start Date
May 8 2020
End Date
June 30 2022
Last Update
August 31 2021
Active Locations (1)
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1
Stone Research Foundation
San Francisco, California, United States, 94123