Brusque

Researchers are evaluating the safety and tolerability of an absorbable oxandrolone implant as an additional treatment during rehabilitation after anterior cruciate ligament (ACL) reconstruction surgery. This phase II, randomized, double-blind, placebo-controlled study compares oxandrolone implants to placebo implants in men and women aged 18 to 60 years. Oxandrolone, a steroid with strong muscle-building effects and fewer side effects, may help improve muscle mass, strength, and functional recovery after ACL surgery. The study also monitors the drug's serum and pharmacokinetic profile. Participants receive subdermal implants delivering oxandrolone or placebo. Men receive two 200 mg implants (total 400 mg), while women receive one 200 mg implant. The treatment starts after surgery, and participants continue standard rehabilitation. The study lasts for 24 weeks, during which the safety and potential benefits of the oxandrolone implant are assessed. During the study, participants undergo regular monitoring for serious adverse events related to treatment through spontaneous reports and clinical findings. Researchers evaluate muscle mass, strength, and functional capacity to explore oxandrolone's effectiveness. Safety assessments include laboratory tests and clinical evaluations. The total duration of participation is 24 weeks, during which adherence to rehabilitation and implant effects are closely observed.