[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590984":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":95,"studyPopulation":86,"armGroups":96,"interventions":109,"overallOfficials":115,"centralContacts":127,"locations":136,"responsibleParty":246,"collaborators":248,"id":252,"slug":253,"hasResults":254,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":254,"sex":260,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":86,"studyType":266,"phases":267,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":139,"whyStopped":86,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},{"fullName":5,"class":6},"Science Valley Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002For clinical findings. The primary endpoint was chosen to determine the occurrence of unacceptable, severe, and clinically significant toxicity of the experimental treatment.","From randomization to the end of study on Week 24.",[14,17,21,24,27,30,34,38,40,42,44],{"measure":15,"description":16,"timeFrame":12},"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\u002For clinical findings.",{"measure":18,"description":19,"timeFrame":20},"Biochemical profile","Composite of the number of participants who experience laboratory values for biochemical, metabolic, hormonal, and haemostasis profile outside the reference range and\u002For deemed clinically significant over the 24 weeks following randomisation.\n\nThe following blood tests will be performed: Biochemical profile: haematocrit, platelet count, creatinine, serum urea, total bilirubin, aspartate aminotransferase (AST\u002FSGOT), alanine aminotransferase (ALT\u002FSGPT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), creatine phosphokinase (CPK), total prostate-specific antigen (PSA).","At pre-insertion, 4, 12, and 24 weeks after randomization",{"measure":22,"description":23,"timeFrame":20},"Metabolic Profile","Composite of the number of participants who experience laboratory values for biochemical, metabolic, hormonal, and haemostasis profile outside the reference range and\u002For deemed clinically significant over the 24 weeks following randomisation. The following blood tests will be performed: Metabolic profile - total cholesterol, LDL, HDL, lipoprotein A.",{"measure":25,"description":26,"timeFrame":20},"Hormonal Profile","Composite of the number of participants who experience laboratory values for biochemical, metabolic, hormonal, and haemostasis profile outside the reference range and\u002For 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).",{"measure":28,"description":29,"timeFrame":20},"Hemostasis Parameters","Composite of the number of participants who experience laboratory values for biochemical, metabolic, hormonal, and haemostasis profile outside the reference range and\u002For 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.",{"measure":31,"description":32,"timeFrame":33},"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\u002FMS) in a central laboratory.","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.",{"measure":35,"description":36,"timeFrame":37},"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\u002FMS)","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.",{"measure":39,"description":36,"timeFrame":37},"Maximum concentration (Cmax)",{"measure":41,"description":36,"timeFrame":37},"Time to reach maximum concentration (tmax)",{"measure":43,"description":36,"timeFrame":37},"Half Life (t1\u002F2)",{"measure":45,"description":46,"timeFrame":47},"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.","At pre-insertion and 4, 12 and 24 weeks after randomization",[49,52,56,59,62,65,68,72,76,80],{"measure":50,"description":51,"timeFrame":47},"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.",{"measure":53,"description":54,"timeFrame":55},"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\u002For better health","At pre-insertion, 12 and 24 weeks after randomization",{"measure":57,"description":58,"timeFrame":55},"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.",{"measure":60,"description":61,"timeFrame":55},"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.",{"measure":63,"description":64,"timeFrame":55},"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.",{"measure":66,"description":67,"timeFrame":55},"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).",{"measure":69,"description":70,"timeFrame":71},"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.","At 24 weeks after randomization",{"measure":73,"description":74,"timeFrame":75},"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.","12 and 24 weeks after randomization",{"measure":77,"description":78,"timeFrame":79},"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.","At pre-insertion and 12 and 24 weeks after randomization",{"measure":81,"description":82,"timeFrame":55},"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).",{"allocation":84,"interventionModel":85,"interventionModelDescription":86,"primaryPurpose":87,"observationalModel":86,"timePerspective":86,"maskingInfo":88},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":89,"maskingDescription":86,"whoMasked":90},"QUADRUPLE",[91,92,93,94],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nThe 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\u002For clinical findings. The primary endpoint was chosen to determine the occurrence of unacceptable, severe, and clinically significant toxicity of the experimental treatment.\n\nThe 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\u002FMS) method. Serum samples will be collected in a subgroup of participants to analyse the pharmacokinetics (Subgroup PK, N = 20 participants).\n\nThe 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.",[97,103],{"label":98,"type":99,"description":100,"interventionNames":101},"Oxandrolone","EXPERIMENTAL","Oxandrolone bioabsorbable implant (subdermal insertion) Men: 400 mg oxandrolone (two 200 mg oxandrolone implants each) Women: 200 mg oxandrolone (one 200 mg oxandrolone implant)",[102],"Drug: Oxandrolone",{"label":104,"type":105,"description":106,"interventionNames":107},"Placebo","PLACEBO_COMPARATOR","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)",[108],"Drug: Placebo",[110,113],{"type":111,"name":98,"description":100,"armGroupLabels":112,"otherNames":86},"DRUG",[98],{"type":111,"name":104,"description":106,"armGroupLabels":114,"otherNames":86},[104],[116,120,124],{"name":117,"affiliation":118,"role":119},"Roberto Tauchmann, MD","Hospital do Rocio","PRINCIPAL_INVESTIGATOR",{"name":121,"affiliation":122,"role":123},"André Malavasi, MD, PhD","Science Valley","STUDY_CHAIR",{"name":125,"affiliation":122,"role":126},"Eduardo Ramacciotti, MD, PhD","STUDY_DIRECTOR",[128,133],{"name":129,"role":130,"phone":131,"phoneExt":86,"email":132},"Leandro B Agati, PhD","CONTACT","+55 11 4040-8670","agati@svriglobal.com",{"name":134,"role":130,"phone":131,"phoneExt":86,"email":135},"Viviane Santana","viviane.santana@svriglobal.com",[137,159,177,195,213,232],{"facility":138,"status":139,"city":140,"state":141,"zip":86,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":149,"contacts":150},"Unimed Fortaleza","RECRUITING","Fortaleza","Ceará","Brazil","BR",{"type":145,"coordinates":146},"Point",[147,148],-38.54306,-3.71722,{"lat":148,"lon":147},[151,156],{"name":152,"role":130,"phone":153,"phoneExt":154,"email":155},"Henrique César Ribeiro, MD","55-85-3277-6304","1342","henrique.ribeiro@unimedfortaleza.com.br",{"name":157,"role":130,"phone":153,"phoneExt":86,"email":158},"Keversson Xavier","keversson.rocha@unimedfortaleza.com.br",{"facility":160,"status":139,"city":161,"state":162,"zip":86,"country":142,"countryCode":143,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Faculdade Ciências Médicas de Minas Gerais (CMMG)","Belo Horizonte","Minas Gerais",{"type":145,"coordinates":164},[165,166],-43.93778,-19.92083,{"lat":166,"lon":165},[169,173],{"name":170,"role":130,"phone":171,"phoneExt":154,"email":172},"Lucas T Galuppo, MD","55-31-2129-9110","lucasgaluppo@gmail.com",{"name":174,"role":130,"phone":175,"phoneExt":86,"email":176},"Michele Pinho","55-31-99895-7175","michele.pinho@feluma.org.br",{"facility":178,"status":139,"city":179,"state":180,"zip":86,"country":142,"countryCode":143,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Centro de Oncologia do Paraná","Curitiba","Paraná",{"type":145,"coordinates":182},[183,184],-49.27306,-25.42778,{"lat":184,"lon":183},[187,191],{"name":188,"role":130,"phone":189,"phoneExt":154,"email":190},"Thadeu T Suzuki, MD","55-41-3083-0899","thadeusuzuki@hotmail.com",{"name":192,"role":130,"phone":193,"phoneExt":86,"email":194},"William Novais","55-41-995548890","william.novais@centrodeoncologia.com",{"facility":196,"status":139,"city":197,"state":198,"zip":86,"country":142,"countryCode":143,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Unimed Brusque","Brusque","Santa Catarina",{"type":145,"coordinates":200},[201,202],-48.91281,-27.09795,{"lat":202,"lon":201},[205,209],{"name":206,"role":130,"phone":207,"phoneExt":154,"email":208},"Daniel T Klein, MD","47-3251-2499","danielrklein@hotmail.com",{"name":210,"role":130,"phone":211,"phoneExt":86,"email":212},"Yasmin Silva","55-47-88727753","yasmin.silva@unimedbrusque.com.br",{"facility":214,"status":139,"city":215,"state":216,"zip":86,"country":142,"countryCode":143,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Hospital e Maternidade Christóvão da Gama","Santo André","São Paulo",{"type":145,"coordinates":218},[219,220],-46.53833,-23.66389,{"lat":220,"lon":219},[223,227],{"name":224,"role":130,"phone":225,"phoneExt":86,"email":226},"Leandro T Okamura, MD","55-11-4040-8670","dr.leandro.okamura83@gmail.com",{"name":228,"role":130,"phone":229,"phoneExt":230,"email":231},"Daniele Komar","55 (11) 4040 8670","8677","daniele.komar@svriglobal.com",{"facility":233,"status":139,"city":234,"state":216,"zip":86,"country":142,"countryCode":143,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Santa Casa de Santos","Santos",{"type":145,"coordinates":236},[237,238],-46.33361,-23.96083,{"lat":238,"lon":237},[241,245],{"name":242,"role":130,"phone":243,"phoneExt":154,"email":244},"Rogério T Nakasone, MD","55-13-3202-0600","rogerio.nakasone@gmail.com",{"name":228,"role":130,"phone":225,"phoneExt":230,"email":231},{"type":247,"investigatorFullName":86,"investigatorTitle":86,"investigatorAffiliation":86,"oldNameTitle":86,"oldOrganization":86},"SPONSOR",[249],{"name":250,"class":251},"Stin Pharma","UNKNOWN","100590984","phase-2-subdermal-implant-bioabsorbable-oxandrolone-pellet-for-rehabilitation-following-anterior-cruciate-ligament-acl-surgical-reconstruction-100590984",false,"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 Oxandrolone Subdermal Bioabsorbable Implant as an Adjuvant Treatment in Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction (IMOX Study)","IMOX","Inclusion Criteria:\n\nFor male and female participants:\n\n* Ability to confirm voluntary participation and approve the Informed Consent Form;\n* Men and women aged 18 to 60 years (inclusive);\n* Body weight between 50-120 kg for men and 40-90 kg for women;\n* BMI ≤34.9 kg\u002Fm²;\n* Complete ACL rupture visualized by pre-operative magnetic resonance imaging (MRI);\n* Having undergone arthroscopic knee surgery for anterior cruciate ligament (ACL) coverage using an autologous hamstring tendon graft;\n* 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.\n* 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;\n\nInclusion criteria assessed at the Randomization Visit (VR\u002FV2):\n\n* Continue to meet all inclusion criteria verified during the Selection Visit (VS\u002FV1)\n* Adherence to the rehabilitation protocol, having initiated postoperative physiotherapy treatment;\n* Functional range of motion from 0 to 120º and ability to ambulate without crutches;\n* Blood pressure in the seated position in the doctor's office \\\u003C180\u002F95 mmHg;\n* Hematocrit ≤ 50%;\n* ALT less than three times the upper limit of normal;\n* Serum creatinine \\\u003C2 mg\u002FdL;\n* Total bilirubin \\\u003C 3.0 mg\u002FdL;\n* Albumin ≥ 3.5 g\u002FdL;\n\nFor male participants only:\n\n\\- Total PSA ≤ 4.1 ng\u002FmL.\n\nExclusion criteria:\n\nFor female participants only:\n\n* Confirmed or suspected pregnancy;\n* History of childbirth, abortion, or lactation in the last 3 months;\n* 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;\n* 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;\n* Polycystic Ovary Syndrome;\n* Known or suspected breast carcinoma;\n\nFor male participants only:\n\n\\- Known or suspected carcinoma of the prostate or male breast;\n\nFor male and female participants:\n\n* Previous serious injury or history of surgery on the lower limbs;\n* Knee injury more than 36 months ago;\n* Meniscal tear requiring repair or suturing during ACL reconstruction surgery that interferes with postoperative rehabilitation (e.g., immobilization or limitation of range of motion);\n* Use of patellar, quadriceps, or other hamstring tendon grafts during ACL reconstruction;\n* Known contraindication to hormone use;\n* Any condition that worsens under hormone treatment;\n* Personal history of deep vein thrombosis (DVT);\n* Known coagulopathy;\n* Known chromosomal disorders;\n* Hypersensitivity to anabolic androgenic steroids;\n* Previous treatment failure with Oxandrolone;\n* Concomitant use of testosterone (or analogues) and other anabolic androgenic steroids, or prior use without completion of an adequate washout period before baseline serum testosterone sampling for study eligibility determination and randomization, in any pharmaceutical formulation within the last 3 months. Practical clinical washout will be based on recovery of baseline serum testosterone levels to \\\u003C300 ng\u002FdL. The minimum recommended washout periods are 2-3 days for transdermal gel formulations, 3 weeks for short-acting testosterone esters (enanthate or cypionate; intramuscular or subcutaneous), and 8 weeks for long-acting testosterone esters (undecanoate; intramuscular).\n* Pituitary tumor;\n* Creatinine levels \\>2 mg\u002FdL or history of chronic kidney disease;\n* Myocardial infarction in the last 6 months;\n* Uncontrolled dyslipidemia;\n* Uncontrolled diabetes;\n* Patients with chronic obstructive pulmonary disease (COPD) unresponsive to bronchodilators;\n* Concomitant use of warfarin or another oral anticoagulant during experimental treatment.\n* Irregularly active type B or sedentary classification on the International Physical Activity Questionnaire (IPAQ), based on pre-ACL injury physical activity;\n* Athlete engaged in paid physical activity;\n* Known psychiatric diagnosis, including disorder Major or persistent depressive disorder, bipolar disorder, anxiety, social phobia, specific phobias or obsessive-compulsive disorder, psychotic disorder, personality disorder, eating disorder, neurocognitive disorders, and developmental or somatoform disorders (somatization or hypochondria);\n* Presence of voiding disorder;\n* Known diagnosis of fibromyalgia;\n* Participation in other clinical trial protocols in the last 30 days;\n* Participant who, in the investigator's opinion, presents other conditions or clinical or laboratory alterations that make them ineligible to participate in the study;\n\nExclusion criteria assessed at the Randomization Visit (VR\u002FV2):\n\n* The participant came to meet any exclusion criterion verified at the Selection Visit (SV\u002FV1);\n* Presenting postoperative complications such as stiffness and\u002For healing in the knee requiring additional procedures.","ALL","18 Years","60 Years",{"count":264,"type":265},96,"ESTIMATED","INTERVENTIONAL",[268],"PHASE2","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.",[271],"Anterior Cruciate Ligament (ACL) Reconstruction",[273,98,274,275,276],"Anterior cruciate ligament (ACL)","Subdermal bioabsorbable implant","Adverse effects","Sarcopenia","2026-08-23",{"date":279,"type":280},"2026-08-25","ACTUAL",{"date":282,"type":280},"2025-11-28",{"date":284,"type":265},"2027-04-30",{"name":5,"class":6},6]