Study of Absorbable Oxandrolone Implant to Support Recovery After ACL Reconstruction Surgery in Adults Ages 18 to 60

What this Trial Is About

Researchers are investigating the safety and tolerability of an absorbable oxandrolone implant used as an additional treatment during rehabilitation after anterior cruciate ligament ACL reconstruction surgery. This phase II, randomized, double-blind, placebo-controlled study aims to assess serious adverse events related to the treatment over 24 weeks and explore its effects on muscle mass, strength, and functional recovery in men and women following ACL surgery. Oxandrolone is an anabolic steroid with high anabolic and low androgenic activity, previously approved for weight loss after trauma or surgery. Participants will receive either the absorbable oxandrolone implant or a placebo implant inserted subdermally. Men will receive two 200 mg implants total 400 mg while women will receive one 200 mg implant. The study monitors the serum and pharmacokinetic profile of oxandrolone up to 24 weeks post-insertion. The study includes regular measurements of androgenization signs, biochemical, metabolic, hormonal profiles, and blood clotting parameters at multiple time points. During the 24-week study, participants will undergo scheduled assessments including clinical evaluations, blood tests for oxandrolone concentration and safety markers at pre-insertion and several intervals up to week 24. Researchers will collect reports of any serious adverse events and monitor functional recovery related to muscle and knee function. The trial lasts 24 weeks after implant insertion, with careful observation of safety and exploratory efficacy throughout this period.

Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction