NCT06974526

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

Randomized, Multicenter, Double-blind, Parallel, Placebo-controlled Study to Investigate the Safety and Exploratory Efficacy of the Absorbable Oxandrolone Implant as an Adjuvant Treatment in Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction (IMOX Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Science Valley Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase II, randomized, double-blind, placebo-controlled, multicenter clinical study designed to evaluate the safety and tolerability profile of the absorbable oxandrolone implant as an adjuvant treatment in rehabilitation following anterior cruciate ligament (ACL) reconstruction surgery. The primary safety outcome will be the incidence of serious adverse events (SAEs) related do treatment collected through spontaneous reports and/or clinical findings over 24 weeks after randomization (subdermal insertion of the absorbable oxandrolone implant). The effectiveness of absorbable oxandrolone implants in the rehabilitation of patients after surgical ACL reconstruction will be evaluated in an exploratory manner, based on their effects on the recovery of muscle mass, muscle strength, and functional capacity.

Conditions

• Anterior Cruciate Ligament (ACL) Reconstruction

Interventions

Type	Name	Description
DRUG	Oxandrolone	Absorbable oxandrolone implant (subdermal insertion) Men: 400 mg oxandrolone (two 200 mg oxandrolone implants each) Women: 200 mg oxandrolone (one 200 mg oxandrolone implant)
DRUG	Placebo	Absorbable placebo implant (excipients; subdermal insertion) Men: 400 mg placebo (two 200 mg placebo implants each) Women: 200 mg placebo (one 200 mg placebo implant)

Timeline

• Start date: 2025-11-28
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2025-05-16
• Last updated: 2026-02-24

Locations

6 sites across 1 country: Brazil