A Phase 2 interventional study of Oxandrolone and Placebo in Anterior Cruciate Ligament (ACL) Reconstruction, sponsored by Science Valley Research Institute. Recruiting at 6 sites in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Science Valley Research Institute · Phase 2, Interventional, and Treatment
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, the National Health Surveillance Agency in 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 oxandrolone subdermal bioabsorbable 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 subdermal bioabsorbable implant will be monitored.
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 96 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For male and female participants:
Inclusion criteria assessed at the Randomization Visit (VR/V2):
For male participants only:
- Total PSA ≤ 4.1 ng/mL.
Exclusion criteria:
For female participants only:
For male participants only:
- Known or suspected carcinoma of the prostate or male breast;
For male and female participants:
Exclusion criteria assessed at the Randomization Visit (VR/V2):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oxandrolone bioabsorbable 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 bioabsorbable 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
Oxandrolone bioabsorbable implant (subdermal insertion) Men: 400 mg oxandrolone (two 200 mg oxandrolone implants each) Women: 200 mg oxandrolone (one 200 mg oxandrolone implant)
Placebo bioabsorbable implant (excipients; subdermal insertion) Men: 400 mg placebo (two 200 mg placebo implants each) Women: 200 mg placebo (one 200 mg placebo implant)
Proportion of participants experiencing at least one serious adverse event (SAE) over 24-week follow-up period
The adverse events will be 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.
Time frame: From randomization to the end of study on Week 24.
Safety profile and tolerability
Assessment of the safety profile based on the incidence of any adverse events (AEs), AEs leading to treatment discontinuation, and AEs related to the local implant insertion reaction. AEs will be collected through spontaneous reports and/or clinical findings.
Time frame: From randomization to the end of study on Week 24.
Biochemical profile
Composite of the number of participants who experience laboratory values for biochemical, metabolic, hormonal, and haemostasis profile outside the reference range and/or deemed clinically significant over the 24 weeks following randomisation. The following blood tests will be performed: Biochemical profile: haematocrit, platelet count, creatinine, serum urea, total bilirubin, aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), creatine phosphokinase (CPK), total prostate-specific antigen (PSA).
Time frame: At pre-insertion, 4, 12, and 24 weeks after randomization
Metabolic Profile
Composite of the number of participants who experience laboratory values for biochemical, metabolic, hormonal, and haemostasis profile outside the reference range and/or deemed clinically significant over the 24 weeks following randomisation. The following blood tests will be performed: Metabolic profile - total cholesterol, LDL, HDL, lipoprotein A.
Time frame: At pre-insertion, 4, 12, and 24 weeks after randomization
Hormonal Profile
Composite of the number of participants who experience laboratory values for biochemical, metabolic, hormonal, and haemostasis profile outside the reference range and/or deemed clinically significant over the 24 weeks following randomisation. The following blood tests will be performed: Hormonal profile: serum concentration of total testosterone, free testosterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH).
Time frame: At pre-insertion, 4, 12, and 24 weeks after randomization
Hemostasis Parameters
Composite of the number of participants who experience laboratory values for biochemical, metabolic, hormonal, and haemostasis profile outside the reference range and/or deemed clinically significant over the 24 weeks following randomisation.The following blood tests will be performed: Haemostasis parameters - D-dimer, SHBG, and free S-protein.
Time frame: At pre-insertion, 4, 12, and 24 weeks after randomization
Total serum oxandrolone concentration
In a subgroup of 20 participants from selected centers, serum oxandrolone concentrations will be assessed to determine the oxandrolone concentration. Serum samples will be processed and stored for analysis by Liquid Chromatography coupled to Tandem Mass Spectrometry (LC-MS/MS) in a central laboratory.
Time frame: Pre-insertion of the bioabsorbable oxandrolone implant and at 24 hours and 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks after implant insertion.
Area under the curve (AUC)
The pharmacokinetic profile of oxandrolone will be characterised in a subgroup of participants (N = 20) by Liquid Chromatography coupled to Tandem Mass Spectrometry (LC-MS/MS)
Time frame: Pre-insertion of the bioabsorbable oxandrolone implant and at 24 hours and 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks after oxandrolone implant insertion.
Maximum concentration (Cmax)
The pharmacokinetic profile of oxandrolone will be characterised in a subgroup of participants (N = 20) by Liquid Chromatography coupled to Tandem Mass Spectrometry (LC-MS/MS)
Time frame: Pre-insertion of the bioabsorbable oxandrolone implant and at 24 hours and 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks after oxandrolone implant insertion.
Time to reach maximum concentration (tmax)
The pharmacokinetic profile of oxandrolone will be characterised in a subgroup of participants (N = 20) by Liquid Chromatography coupled to Tandem Mass Spectrometry (LC-MS/MS)
Time frame: Pre-insertion of the bioabsorbable oxandrolone implant and at 24 hours and 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks after oxandrolone implant insertion.
Half Life (t1/2)
The pharmacokinetic profile of oxandrolone will be characterised in a subgroup of participants (N = 20) by Liquid Chromatography coupled to Tandem Mass Spectrometry (LC-MS/MS)
Time frame: Pre-insertion of the bioabsorbable oxandrolone implant and at 24 hours and 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks after oxandrolone implant insertion.
Participants who experience androgenization
The appearance and worsening of signs of androgenization in female participants will be monitored at all clinical visits throughout the study. A physician or other qualified professional will assess hirsutism, alopecia, and acne, and the assessment of voice deepening will be performed by the participant´s self-report.
Time frame: At pre-insertion and 4, 12 and 24 weeks after randomization
Anthropometric Measurement Assessment
Measurements of weight, height, waist circumference, and hip circumference should be collected to calculate anthropometric indices related to cardiovascular risk in the development of diseases and comorbidities: Body Mass Index (BMI), Body Adiposity Index (BAI), Waist-to-Hip Ratio (WHR), and Waist-to-Height Ratio (WHR). The parameters will be collected during the physical examination at all in-person visits.
Time frame: At pre-insertion and 4, 12 and 24 weeks after randomization
Changes in the Short Form Health Survey SF-36 Quality of Life Questionnaire
Number of participants with changes in the 36-Item Short Form Health Survey (SF-36). SF-36 is a patient-reported outcome (PRO) measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health
Time frame: At pre-insertion, 12 and 24 weeks after randomization
Changes in the General Anxiety Disorder Questionnaire (GAD-7)
The GAD-7 is a self-administered questionnaire that assesses generalized anxiety, composed of seven questions covering aspects such as excessive worry, difficulty controlling worry, irritability, muscle tension, fatigue, difficulty relaxing, and sleep problems. Each question is scored from 0 to 3, with a severity score ranging from 0 to 21. Cutoff points are ≥5 for mild anxiety, ≥10 for moderate anxiety, and ≥15 for severe anxiety.
Time frame: At pre-insertion, 12 and 24 weeks after randomization
Changes in the Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a self-administered questionnaire focused on depression, consisting of nine questions addressing aspects like diminished interest, depressed mood, fatigue, sleep issues, appetite changes, low self-esteem, difficulty concentrating, slowed movements or agitation, and suicidal thoughts. Each question is scored from 0 to 3, with a severity score from 0 to 27. Severe depression is indicated by a score \>16.
Time frame: At pre-insertion, 12 and 24 weeks after randomization
Changes in the Patient Acceptable Symptom State (PAS)
The PAS is a method used to assess whether the current symptom state of a patient is acceptable to them, considering their personal perspective of well-being and functionality. It consists of a single standardized question that captures the patient's global satisfaction with their current condition.
Time frame: At pre-insertion, 12 and 24 weeks after randomization
Changes in the Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale provides a quantification of knee function, allowing comparison of a patient's progress over time. It consists of 8 items. These items are divided into two categories: (1) Symptoms, which evaluate pain, locking, and instability; and (2) Function, which assesses the ability to climb stairs, run, perform daily activities, and squat. The participant responds to each item, which is scored according to the severity or frequency of the symptoms. The total score ranges from 0 to 100 points, with 100 representing the best possible outcome (indicating ideal knee function) and 0 representing the worst outcome (indicating severe dysfunction or disability of the knee).
Time frame: At pre-insertion, 12 and 24 weeks after randomization
Satisfaction with Treatment
Participants will be asked to rate their satisfaction by choosing one of the following options (ranging from 1 to 5): very satisfied, satisfied, not sure, dissatisfied, or very dissatisfied.
Time frame: At 24 weeks after randomization
Changes in the Y Balance Test
Changes in the Y Balance Test will be conducted in a subgroup of participants at selected research centres with appropriate infrastructure available (N = 40). The Y Balance Test is a functional assessment used to measure mobility, muscle strength, and trunk and lower limb stability. It is used to identify muscle imbalances, strength deficiencies, and injury risks in individuals recovering from injuries. The final test score is the distance reached in each direction, expressed as a percentage of leg length (adjusting the results based on body size). Comparisons are made between limbs (right leg vs. left leg) to check for symmetry and identify possible deficiencies or imbalances. The patient must achieve less than 4cm of anterior reach difference between legs.
Time frame: 12 and 24 weeks after randomization
Changes in body composition
Changes in body composition will be conducted in a subgroup of participants at selected research centres with appropriate infrastructure available (N = 40). Bioimpedance is a non-invasive procedure that measures a person's body composition. Four electrodes are applied to the participant's hands and feet. The equipment emits a mild electrical current that passes between the individual's body tissues. The device detects the voltage drop caused by impedance and identifies the body's resistance and reactance. In this way, the participant's lean mass (Kg) and fat mass (%) are obtained.
Time frame: At pre-insertion and 12 and 24 weeks after randomization
Changes in maximal muscle strength using isometric dynamometry
Changes in maximal muscle strength will be conducted in a subgroup of participants at selected research centres with appropriate infrastructure available (N = 40).The Isometric dynamometry evaluates isometric strength using the Lafayette Isometric Hand Dynamometer or its national equivalent. The evaluation will be performed by a physiotherapist on the study team for the knee extensors and flexors. The parameters used in the assessment are defined by the literature: normalisation and symmetry index; peak torque (Nm) of the quadriceps and hamstring; limb symmetry index (LSI).
Time frame: At pre-insertion, 12 and 24 weeks after randomization
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Studies of the drug tested here: Oxandrolone
Science Valley Research Institute