Actively Recruiting
Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction
Led by Science Valley Research Institute · Updated on 2026-02-24
96
Participants Needed
6
Research Sites
74 weeks
Total Duration
On this page
Sponsors
S
Science Valley Research Institute
Lead Sponsor
S
Stin Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 60 years
- Ability to give voluntary consent and approve informed consent form
- Body weight between 50-120 kg for men and 40-90 kg for women
- BMI less than or equal to 34.9 kg/m²
- Complete ACL rupture confirmed by pre-operative MRI
- Underwent arthroscopic knee surgery for ACL reconstruction using autologous hamstring tendon graft
- Isolated ACL injury or combined with ligamentous, meniscal, or cartilage lesions that do not interfere with rehabilitation
- Classified as very active, active, or irregularly active type A on IPAQ before ACL injury
- Started postoperative physiotherapy and adhere to rehabilitation protocol
- Functional knee range of motion from 0 to 120 degrees and able to walk without crutches
- Blood pressure below 180/95 mmHg seated in doctor's office
- Hematocrit less than or equal to 50%
- ALT less than three times upper limit of normal
- Serum creatinine less than 2 mg/dL
- Total bilirubin less than 3.0 mg/dL
- Albumin greater than or equal to 3.5 g/dL
- For men only: Total PSA less than or equal to 4.1 ng/mL
You will not qualify if you...
- For women: Confirmed or suspected pregnancy
- For women: Childbirth, abortion, or lactation in last 3 months
- For women: Refusal to use allowed contraceptives during study and 90 days after
- For women: Signs of hyperandrogenization such as hirsutism, alopecia, or severe acne
- For women: Polycystic Ovary Syndrome
- For women: Known or suspected breast cancer
- For men: Known or suspected prostate or male breast cancer
- Previous serious injury or surgery on lower limbs
- Knee injury older than 36 months
- Unstable meniscal tear needing repair that interferes with rehabilitation
- Meniscus suture during ACL reconstruction
- Use of patellar, quadriceps, or other hamstring grafts during ACL reconstruction
- Contraindication to hormone use or conditions worsened by hormone treatment
- Personal history of deep vein thrombosis or known coagulopathy
- Known chromosomal disorders
- Hypersensitivity to anabolic steroids
- Previous failure with oxandrolone treatment
- Use of testosterone or anabolic steroids in last 3 months
- Pituitary tumor
- Creatinine over 2 mg/dL or chronic kidney disease
- Myocardial infarction in last 6 months
- Uncontrolled dyslipidemia or diabetes
- COPD unresponsive to bronchodilators
- Contraindication to MRI or claustrophobia
- Irregularly active type B or sedentary on IPAQ
- Paid athlete
- Known psychiatric disorders
- Voiding disorder
- Fibromyalgia diagnosis
- Current smoking
- History of drug abuse
- Participation in other trials in last 30 days
- Other clinical or lab conditions making participation unsafe
- Postoperative complications requiring additional knee procedures such as stiffness or healing issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Unimed Fortaleza
Fortaleza, Ceará, Brazil
Actively Recruiting
2
Faculdade Ciências Médicas de Minas Gerais (CMMG)
Belo Horizonte, Minas Gerais, Brazil
Actively Recruiting
3
Centro de Oncologia do Paraná
Curitiba, Paraná, Brazil
Actively Recruiting
4
Unimed Brusque
Brusque, Santa Catarina, Brazil
Actively Recruiting
5
Hospital e Maternidade Christóvão da Gama
Santo André, São Paulo, Brazil
Actively Recruiting
6
Santa Casa de Santos
Santos, São Paulo, Brazil
Actively Recruiting
Research Team
L
Leandro B Agati, PhD
CONTACT
V
Viviane Santana
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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