Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2026-05-11

Target enrollment:

Participant gender:

Summary

Rehabilitation of knee stability and function after anterior cruciate ligament (ACL) reconstruction is slow and costly. The use of anabolic steroids, such as oxandrolone, may aid in the recovery of muscle mass and strength, as well as functional capacity. Oxandrolone, derived from dihydrotestosterone, has high anabolic activity and low androgenic activity (a 13:1 ratio), making it more effective in promoting weight gain with fewer side effects compared to other steroids. Registered by the FDA and previously by ANVISA (National Health Surveillance Agency (Brazil), it is indicated for cases of post-trauma or post-surgery weight loss. The subdermal use of oxandrolone implants is proposed to release the drug directly into the bloodstream, improving efficacy and reducing issues related to oral administration. This study evaluates the safety and tolerability of the absorbable subdermal oxandrolone implant for 24 weeks versus placebo implant in both men and women as an adjuvant treatment during rehabilitation following anterior cruciate ligament (ACL) surgical reconstruction. The serum and pharmacokinetic profile of the oxandrolone implant will be monitored.

Phase:

PHASE2

Details

Lead Sponsor:

Science Valley Research Institute

Collaborator:

Stin Pharma

Treatments:

Oxandrolone