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

NCT06974526 | Recruiting Phase 2 DMC

• 1 other identifier: IMOX
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction

Keywords

Anterior cruciate ligament (ACL); Oxandrolone; Absorbable subdermal implant; Adverse effects; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Combination of serious adverse events (SAEs) related to treatment accumulated within 24 weeks of oxandrolone or placebo pellet insertion and collected through spontaneous reporting and/or clinical findings

  The primary safety outcome is a composite of serious adverse events (SAEs) related to treatment accumulated over 24 weeks following oxandrolone or placebo implant insertion, collected from the time of informed consent signature through spontaneous reports and clinical findings.

  From randomization to the end of study on Week 24.

Secondary Outcomes (10)

• Participants who experience androgenization

  At pre-insertion and 4, 12 and 24 weeks after randomization

• Biochemical profile

  At pre-insertion, 4, 12, and 24 weeks after randomization

• Metabolic Profile

  At pre-insertion, 4, 12, and 24 weeks after randomization

• Hormonal Profile

  At pre-insertion, 4, 12, and 24 weeks after randomization

• Hemostasis Parameters

  At pre-insertion, 4, 12, and 24 weeks after randomization

Other Outcomes (11)

• Anthropometric Measurement Assessment

  At pre-insertion and 4, 12 and 24 weeks after randomization

• Changes in the Short Form Health Survey SF-36 Quality of Life Questionnaire

  At pre-insertion, 12 and 24 weeks after randomization

• Changes in the General Anxiety Disorder Questionnaire (GAD-7)

  At pre-insertion, 12 and 24 weeks after randomization

Study Arms (2)

Oxandrolone

EXPERIMENTAL

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: Oxandrolone

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

Placebo DRUG

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)

Placebo

Oxandrolone DRUG

Absorbable oxandrolone implant (subdermal insertion) Men: 400 mg oxandrolone (two 200 mg oxandrolone implants each) Women: 200 mg oxandrolone (one 200 mg oxandrolone implant)

Oxandrolone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• For male and female participants:
• Ability to confirm voluntary participation and approve the Informed Consent Form;
• Men and women aged 18 to 60 years (inclusive);
• Body weight between 50-120 kg for men and 40-90 kg for women;
• BMI ≤34.9 kg/m²;
• Complete ACL rupture visualized by pre-operative magnetic resonance imaging (MRI);
• Having undergone arthroscopic knee surgery for anterior cruciate ligament (ACL) coverage using an autologous hamstring tendon graft;
• Presenting with an isolated ACL injury or combined with ligamentous, meniscal, or cartilage lesions visualized by MRI, provided they do not interfere with the rehabilitation protocol.
• Classification as very active, active, or irregularly active type A according to the International Physical Activity Questionnaire (IPAQ), based on pre-ACL injury physical activity;
• Adherence to the rehabilitation protocol, having initiated postoperative physiotherapy treatment;
• Functional range of motion from 0 to 120º and ability to ambulate without crutches;
• Blood pressure in the seated position in the doctor's office \<180/95 mmHg;
• Hematocrit ≤ 50%;
• ALT less than three times the upper limit of normal;
• Serum creatinine \<2 mg/dL;

You may not qualify if:

• For female participants only:
• Confirmed or suspected pregnancy;
• History of childbirth, abortion, or lactation in the last 3 months;
• Refusal to use permitted contraceptive methods during the study and for 90 days after the end of participation in the study, unless surgically sterile or expressly declaring themselves exempt from the risk of pregnancy due to not engaging in sexual activity or engaging in non-reproductive activity;
• Clinical signs of hyperandrogenization characterized by: hirsutism defined by a Ferriman-Gallwey score ≥ 8; or alopecia defined by hair loss of at least 50% of the participant's normal hair, which is not obvious from a distance but is only noticeable upon closer inspection; a different haircut may be necessary to cover the hair loss, but does not necessarily require a wig or hairpiece to camouflage it; or Grade 5 acne defined by a predominance of inflammatory acne lesions in the facial area;
• Polycystic Ovary Syndrome;
• Known or suspected breast carcinoma;
• For male participants only:
• \- Known or suspected carcinoma of the prostate or male breast;
• For male and female participants:
• Previous serious injury or history of surgery on the lower limbs;
• Knee injury more than 36 months ago;
• Unstable longitudinal meniscal tear requiring repair where subsequent postoperative treatment (e.g., immobilization and range of motion limitation) interferes with the rehabilitation protocol;
• Meniscus suture during ACL reconstruction;
• Use of patellar, quadriceps, or other hamstring tendon grafts during ACL reconstruction;

Sponsors & Collaborators

• Stin Pharma: collaborator
• Science Valley Research Institute: lead

Study Sites (6)

Unimed Fortaleza

Fortaleza, Ceará, Brazil

RECRUITING

Faculdade Ciências Médicas de Minas Gerais (CMMG)

Belo Horizonte, Minas Gerais, Brazil

RECRUITING

Centro de Oncologia do Paraná

Curitiba, Paraná, Brazil

RECRUITING

Unimed Brusque

Brusque, Santa Catarina, Brazil

RECRUITING

Hospital e Maternidade Christóvão da Gama

Santo André, São Paulo, Brazil

RECRUITING

Santa Casa de Santos

Santos, São Paulo, Brazil

RECRUITING

Related Publications (5)

• Weber AE, Gallo MC, Bolia IK, Cleary EJ, Schroeder TE, Rick Hatch GF 3rd. Anabolic Androgenic Steroids in Orthopaedic Surgery: Current Concepts and Clinical Applications. J Am Acad Orthop Surg Glob Res Rev. 2022 Jan 4;6(1):e21.00156. doi: 10.5435/JAAOSGlobal-D-21-00156.

  PMID: 34982051 BACKGROUND

• Orr R, Fiatarone Singh M. The anabolic androgenic steroid oxandrolone in the treatment of wasting and catabolic disorders: review of efficacy and safety. Drugs. 2004;64(7):725-50. doi: 10.2165/00003495-200464070-00004.

  PMID: 15025546 BACKGROUND

• Thomas AC, Wojtys EM, Brandon C, Palmieri-Smith RM. Muscle atrophy contributes to quadriceps weakness after anterior cruciate ligament reconstruction. J Sci Med Sport. 2016 Jan;19(1):7-11. doi: 10.1016/j.jsams.2014.12.009. Epub 2015 Jan 13.

  PMID: 25683732 BACKGROUND

• Bauman WA, Spungen AM, Collins JF, Raisch DW, Ho C, Deitrick GA, Nemchausky BA, Goetz LL, Park JS, Schwartz M, Merritt JL, Jayawardena V, Sandford P, Sabharwal S, Holmes SA, Nasar F, Sasaki R, Punj V, Zachow KF, Chua WC, Thomas MD, Trincher RC. The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial. Ann Intern Med. 2013 May 21;158(10):718-26. doi: 10.7326/0003-4819-158-10-201305210-00006.

  PMID: 23689765 BACKGROUND

• 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.

  PMID: 28840147 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Oxandrolone

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Roberto Tauchmann, MD

  Hospital do Rocio

  PRINCIPAL INVESTIGATOR

• André Malavasi, MD, PhD

  Science Valley

  STUDY CHAIR

• Eduardo Ramacciotti, MD, PhD

  Science Valley

  STUDY DIRECTOR

Central Study Contacts

Leandro B Agati, PhD

CONTACT

+55 11 4040-8670; agati@svriglobal.com

Viviane Santana

CONTACT

+55 11 4040-8670; viviane.santana@svriglobal.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 16, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

BR (6)