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New treatment option for Anterior Cruciate Ligament (ACL) Reconstruction
Official title Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction
ClinicalTrials.gov ID: NCT06974526
What this study is testing
What is Oxandrolone?
Oxandrolone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anterior cruciate ligament (acl) reconstruction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join 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;
You likely can't join 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...
- Clinical signs of hyperandrogenization characterized by: hirsutism defined by a Ferriman-Gallwey score ≥ 8; or alopecia defined by hair loss of at...
- Polycystic Ovary Syndrome;
See the full eligibility criteria
- 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;
- Total bilirubin \< 3.0 mg/dL;
- Albumin ≥ 3.5 g/dL; For male participants only: \- Total PSA ≤ 4.1 ng/mL.
- 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...
- 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...
- 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;
- Known contraindication to hormone use;
- Any condition that worsens under hormone treatment;
- Personal history of deep vein thrombosis (DVT);
- Known coagulopathy;
- Known chromosomal disorders;
- Hypersensitivity to anabolic androgenic steroids;
- Previous treatment failure with Oxandrolone;
- Use of testosterone (or analogues) and other anabolic androgenic steroids in any pharmaceutical form in the last 3 months;
- Pituitary tumor;
- Creatinine levels \>2 mg/dL or history of chronic kidney disease;
- Myocardial infarction in the last 6 months;
- Uncontrolled dyslipidemia;
- Uncontrolled diabetes;
- Patients with chronic obstructive pulmonary disease (COPD) unresponsive to bronchodilators;
- Any contraindication to magnetic resonance imaging (MRI);
- Claustrophobia;
- Irregularly active type B or sedentary classification on the International Physical Activity Questionnaire (IPAQ), based on pre-ACL injury physical activity;
- Athlete engaged in paid physical activity;
- Known psychiatric diagnosis, including disorder Major or persistent depressive disorder, bipolar disorder, anxiety, social phobia, specific phobias or obsessive-compulsive disorder, psychotic disorder, personality...
- Presence of voiding disorder;
- Known diagnosis of fibromyalgia;
- Current smoking;
- History of drug abuse;
- Participation in other clinical trial protocols in the last 30 days;
- Participant who, in the investigator's opinion, presents other conditions or clinical or laboratory alterations that make them ineligible to participate in the study;
- The participant came to meet any exclusion criterion verified at the Selection Visit (SV/V1);
- Presenting postoperative complications such as stiffness and/or healing in the knee requiring additional procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Fortaleza, Ceará, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Curitiba, Paraná, Brazil
- Brusque, Santa Catarina, Brazil
- Santo André, São Paulo, Brazil
- Santos, São Paulo, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fortaleza, Ceará, Brazil; Belo Horizonte, Minas Gerais, Brazil; Curitiba, Paraná, Brazil; Brusque, Santa Catarina, Brazil; Santo André, São Paulo, Brazil; Santos, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.