drugset / Trial / NCT01595581
Testosterone Administration and ACL Reconstruction in Men
Phase 3
Completed
14 enrolled
University of Southern California
Boston University · collabUniversity of Oregon · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
This study is being done to test whether taking testosterone can prevent loss of muscle mass and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential for the development of male reproductive tissues and promotes increased muscle, bone mass, and the growth of body hair. The investigators hope to learn whether testosterone given before and after ACL reconstructive surgery will increase muscle mass and strength and potentially improve recovery time following surgery.
Timeline
- Start
- 2012-04
- Primary completion
- 2015-05
- Completion
- 2015-05
Publications
- Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.
- Wu BW, Berger M, Sum JC, Hatch GF 3rd, Schroeder ET. Randomized control trial to evaluate the effects of acute testosterone administration in men on muscle mass, strength, and physical function following ACL reconstructive surgery: rationale, design, methods. BMC Surg. 2014 Dec 6;14:102. doi: 10.1186/1471-2482-14-102.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone | Small molecule | 200 mg | Intramuscular |