Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
Status unconfirmed · Phase 2/Phase 3
Conditions studied: Muscle Atrophy, Surgery, Knee Injuries and Disorders, Complication of Surgical Procedure, Trauma
In brief
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 been investigated, this study could prove short-term use of testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM) testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and manual measurements of quadriceps cross-section.
Key facts
- Study ID
- NCT04456530
- Run by
- The Stone Research Foundation for Sports Medicine and Arthritis
- People needed
- 15
- Starts
- 2020-05-08
- Expected to finish
- 2022-06-30
- Last updated by the study team
- 2021-08-31
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Males age 18-65.
- Undergoing significant knee surgery such as partial/total knee replacement, ligament reconstruction, meniscus surgeries or articular cartilage paste grafting.
You may not qualify if…
- 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.
Where it is running
- Stone Research Foundation — San Francisco, California, United States
Full record on ClinicalTrials.gov
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