Last updated 44 days ago

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

96 patients around the world
Available in Brazil
This is an exploratory phase II, randomized, double-blind, placebo-controlled, multicenter clinical study designed to evaluate the safety and tolerability profile of the oxandrolone subdermal bioabdorbable implant as an adjuvant treatment in rehabilitation following anterior cruciate ligament (ACL) reconstruction surgery. The primary safety outcome will be the proportion of participants experiencing at least one serious adverse event (SAE) over 24-week follow-up period, collected through spontaneous reports and/or clinical findings. The primary endpoint was chosen to determine the occurrence of unacceptable, severe, and clinically significant toxicity of the experimental treatment. The delivery profile of the subdermal bioabsorbable implant will be assessed in the by the quantification of oxandrolone over 24-week follow-up period, using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Serum samples will be collected in a subgroup of participants to analyse the pharmacokinetics (Subgroup PK, N = 20 participants). The effectiveness of the oxandrolone subdermal bioabsorbable implant 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.
Science Valley Research Institute
96Patients around the world

This study is for people with

Ligament Rupture
Anterior Cruciate Ligament Rupture

Requirements for the patient

To 60 Years
All Gender

Medical requirements

Men and women aged between 18 and 45 years old.
Body weight between 50-110 kg for men and 40-90 kg for women.
BMI ≤30.
Complete rupture of the ACL as visualized by pre-operative magnetic resonance imaging.
Pre-operative radiographic examination with normal joint condition.
Having undergone knee arthroscopy surgery for anterior cruciate ligament reconstruction using autologous hamstring tendon graft.
No other associated injuries, such as posterior cruciate ligament (PCL) injury, grade III medial collateral ligament (MCL) injury, or severe concomitant injury in the contralateral knee (LCL).
Very active, active, or irregularly active classification of type A or B by the International Physical Activity Questionnaire (IPAQ).
Continuation of meeting all inclusion criteria verified at the Screening Visit (SV/V1).
Adherence to the rehabilitation protocol, having participated in at least 10 physical therapy sessions since the SV/V1.
Functional range of motion from 0 to 120º and ability to walk without the aid of crutches.
Sitting blood pressure in the clinic <180/95 mmHg.
Hematocrit ≤ 50%.
ALT less than three times the upper limit of normal.
Serum creatinine <2 mg/dl.
Bilirubin < 3.0 mg/dl.
Albumin <3 g/dl or prealbumin <10 mg/dl.
PSA ≤ 4.1 ng/ml (men only).
Only for female participants: Confirmed or suspected pregnancy.
Only for female participants: History of childbirth, miscarriage, or lactation within the past 3 months.
Only for female participants: Refusal to use permitted contraceptive methods during the study and for 90 days after study completion, unless surgically sterile or expressly declaring to be at no risk of pregnancy due to abstinence or non-reproductive sexual practices.
Only for female participants: Clinical signs of hyperandrogenism.
Only for female participants: Polycystic Ovary Syndrome (PCOS).
Only for female participants: Known or suspected breast carcinoma.
Only for male participants: Known or suspected prostate or male breast carcinoma.
For both male and female participants:
Previous severe injury or history of surgery on the lower limbs.
For both male and female participants: Knee injury older than 12 months.
For both male and female participants: Unstable longitudinal meniscal tear.
For both male and female participants: Meniscus suture during ACL surgical reconstruction.
For both male and female participants: Use of patellar, quadriceps, or any graft other than hamstring tendon during ACL surgical reconstruction.
For both male and female participants: Known contraindication to hormone use.
For both male and female participants: Any condition that worsens with hormonal treatment.
For both male and female participants: Personal history of deep vein thrombosis (DVT).
For both male and female participants: Known coagulopathy.
For both male and female participants: Known chromosomal disorders.
For both male and female participants: Hypersensitivity to anabolic androgenic steroids.
For both male and female participants: Previous failure of oxandrolone treatment.
For both male and female participants: Use of testosterone (or analogs) and other anabolic androgenic steroids in any pharmaceutical form within the last 3 months.
For both male and female participants: Pituitary tumor.
For both male and female participants: Creatinine levels >2 mg/dl or history of chronic kidney disease.
For both male and female participants: Myocardial infarction within the last 6 months.
For both male and female participants: Uncontrolled dyslipidemia.
For both male and female participants: Uncontrolled diabetes.
For both male and female participants: Patients with chronic obstructive pulmonary disease (COPD) not responsive to bronchodilators.
For both male and female participants: Any contraindication to undergoing magnetic resonance imaging (MRI).
For both male and female participants: Claustrophobia.
For both male and female participants: Sedentary classification according to the International Physical Activity Questionnaire (IPAQ).
For both male and female participants: High-performance athlete.
For both male and female participants: Known psychiatric diagnosis, including major or persistent depressive disorder, bipolar disorder, anxiety disorders, social phobia, specific phobias, obsessive-compulsive disorder, psychotic disorders, personality disorders, eating disorders, neurocognitive disorders, developmental disorders, or somatoform disorders (somatization or hypochondriasis).
For both male and female participants: Presence of urinary disorders.
For both male and female participants: Known diagnosis of fibromyalgia.
For both male and female participants: Current smoking.
For both male and female participants: History of drug abuse.
For both male and female participants: Participation in other clinical trial protocols within the past 30 days.
For both male and female participants: Participant who, in the investigator's opinion, presents other conditions or clinical/laboratory abnormalities that make them unsuitable to participate in the study.
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