Anterior Cruciate Ligament (ACL) ReconstructionPhase 2IMOXNCT06974526
Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction
A Phase 2 study testing Oxandrolone in people with Anterior Cruciate Ligament (ACL) Reconstruction, run by Science Valley Research Institute at 6 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Reconstruction
- What is being tested?
- Oxandrolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 6 sitesBrazil
- Study dates
- 28 Nov 2025to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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);
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- 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;
- Inclusion criteria assessed at the Randomization Visit (VR/V2):
- Continue to meet all inclusion criteria verified during the Selection Visit (VS/V1)
- 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.
Who cannot join
- 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 due to not engaging in sexual activity or engaging in non-reproductive activity;
- 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;
- Polycystic Ovary Syndrome;
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- 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;
- Meniscal tear requiring repair or suturing during ACL reconstruction surgery that interferes with postoperative rehabilitation (e.g., immobilization or limitation of range of motion);
- 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;
- 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 <300 ng/dL. 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).
- 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;
- Concomitant use of warfarin or another oral anticoagulant during experimental treatment.
- 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 disorder, eating disorder, neurocognitive disorders, and developmental or somatoform disorders (somatization or hypochondria);
- Presence of voiding disorder;
- Known diagnosis of fibromyalgia;
- 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;
- Exclusion criteria assessed at the Randomization Visit (VR/V2):
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Brazil6 sites, 6 recruiting
- Recruiting
Faculdade Ciências Médicas de Minas Gerais (CMMG)
Belo Horizonte, Minas Gerais
Lucas T Galuppo, MD, 55-31-2129-9110 ext. 1342, lucasgaluppo@gmail.com
Michele Pinho, 55-31-99895-7175, michele.pinho@feluma.org.br
- Recruiting
Unimed Brusque
Brusque, Santa Catarina
Daniel T Klein, MD, 47-3251-2499 ext. 1342, danielrklein@hotmail.com
Yasmin Silva, 55-47-88727753, yasmin.silva@unimedbrusque.com.br
- Recruiting
Centro de Oncologia do Paraná
Curitiba, Paraná
Thadeu T Suzuki, MD, 55-41-3083-0899 ext. 1342, thadeusuzuki@hotmail.com
William Novais, 55-41-995548890, william.novais@centrodeoncologia.com
- Recruiting
Unimed Fortaleza
Fortaleza, Ceará
Henrique César Ribeiro, MD, 55-85-3277-6304 ext. 1342, henrique.ribeiro@unimedfortaleza.com.br
Keversson Xavier, 55-85-3277-6304, keversson.rocha@unimedfortaleza.com.br
- Recruiting
Hospital e Maternidade Christóvão da Gama
Santo André, São Paulo
Leandro T Okamura, MD, 55-11-4040-8670, dr.leandro.okamura83@gmail.com
Daniele Komar, 55 (11) 4040 8670 ext. 8677, daniele.komar@svriglobal.com
- Recruiting
Santa Casa de Santos
Santos, São Paulo
Rogério T Nakasone, MD, 55-13-3202-0600 ext. 1342, rogerio.nakasone@gmail.com
Daniele Komar, 55-11-4040-8670 ext. 8677, daniele.komar@svriglobal.com
About this study
Official title: 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)
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.
Read the detailed description
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.
- Being tested
- Oxandrolone, Placebo
- Keywords
- Anterior cruciate ligament (ACL), Oxandrolone, Subdermal bioabsorbable implant, Adverse effects, Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxandroloneDrug
Oxandrolone bioabsorbable implant (subdermal insertion) Men: 400 mg oxandrolone (two 200 mg oxandrolone implants each) Women: 200 mg oxandrolone (one 200 mg oxandrolone implant)
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Oxandrolone |
| 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to the end of study on Week 24.
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: At pre-insertion and 4, 12 and 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start28 Nov 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament (ACL) ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science Valley Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stin Pharma
- Responsible party
- Sponsor
- Investigators
- Roberto Tauchmann, MD, Principal investigator, Hospital do RocioAndré Malavasi, MD, PhD, Study chair, Science ValleyEduardo Ramacciotti, MD, PhD, Study director, Science Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974526
- Sponsor's protocol ID
- IMOX
- Acronym
- IMOX
- Status last verified
- Aug 2026
- First submitted
- 28 Apr 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weber AE, Gallo MC, Bolia IK, Cleary EJ, Schroeder TE, Rick Hatch GF 3rd. Anabolic Androgenic Steroids in Orthopaedic Surgery: Current Concepts and Clinical Applications. J Am Acad Orthop Surg Glob Res Rev. 2022 Jan 4;6(1):e21.00156. doi: 10.5435/JAAOSGlobal-D-21-00156.
PubMed 34982051Orr R, Fiatarone Singh M. The anabolic androgenic steroid oxandrolone in the treatment of wasting and catabolic disorders: review of efficacy and safety. Drugs. 2004;64(7):725-50. doi: 10.2165/00003495-200464070-00004.
PubMed 15025546Thomas AC, Wojtys EM, Brandon C, Palmieri-Smith RM. Muscle atrophy contributes to quadriceps weakness after anterior cruciate ligament reconstruction. J Sci Med Sport. 2016 Jan;19(1):7-11. doi: 10.1016/j.jsams.2014.12.009. Epub 2015 Jan 13.
PubMed 25683732Bauman WA, Spungen AM, Collins JF, Raisch DW, Ho C, Deitrick GA, Nemchausky BA, Goetz LL, Park JS, Schwartz M, Merritt JL, Jayawardena V, Sandford P, Sabharwal S, Holmes SA, Nasar F, Sasaki R, Punj V, Zachow KF, Chua WC, Thomas MD, Trincher RC. The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial. Ann Intern Med. 2013 May 21;158(10):718-26. doi: 10.7326/0003-4819-158-10-201305210-00006.
PubMed 23689765Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.
PubMed 28840147
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06974526
- Acronym / sponsor ID
- IMOX / IMOX
- Keywords
- Anterior cruciate ligament (ACL), Oxandrolone, Subdermal bioabsorbable implant, Adverse effects, Sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Science Valley Research InstituteUniversity, hospital or other
- Collaborators
- Stin Pharma
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxandrolone | Experimental | Drug: OxandroloneOxandrolone bioabsorbable implant (subdermal insertion) Men: 400 mg oxandrolone (two 200 mg oxandrolone implants each) Women: 200 mg oxandrolone (one 200 mg oxandrolone implant) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo bioabsorbable implant (excipients; subdermal insertion) Men: 400 mg placebo (two 200 mg placebo implants each) Women: 200 mg placebo (one 200 mg placebo implant) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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);
Key exclusion criteria (39 listed)
- 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 due to not engaging in sexual activity or engaging in non-reproductive activity;
- 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;
- Polycystic Ovary Syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxandroloneOxandrolone 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 |
| PlaceboPlacebo 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 |
Primary outcome
Proportion of participants experiencing at least one serious adverse event (SAE) over 24-week follow-up period
Time frame: From randomization to the end of study on Week 24.
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.
11 secondary outcomes
Safety profile and tolerability
Time frame: From randomization to the end of study on Week 24.
Biochemical profile
Time frame: At pre-insertion, 4, 12, and 24 weeks after randomization
Metabolic Profile
Time frame: At pre-insertion, 4, 12, and 24 weeks after randomization
Hormonal Profile
Time frame: At pre-insertion, 4, 12, and 24 weeks after randomization
Hemostasis Parameters
Time frame: At pre-insertion, 4, 12, and 24 weeks after randomization
Total serum oxandrolone concentration
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)
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)
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)
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)
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
Time frame: At pre-insertion and 4, 12 and 24 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 34982051Weber AE, Gallo MC, Bolia IK, Cleary EJ, Schroeder TE, Rick Hatch GF 3rd. Anabolic Androgenic Steroids in Orthopaedic Surgery: Current Concepts and Clinical Applications. J Am Acad Orthop Surg Glob Res Rev. 2022 Jan 4;6(1):e21.00156. doi: 10.5435/JAAOSGlobal-D-21-00156.
- Background: PubMed 15025546Orr R, Fiatarone Singh M. The anabolic androgenic steroid oxandrolone in the treatment of wasting and catabolic disorders: review of efficacy and safety. Drugs. 2004;64(7):725-50. doi: 10.2165/00003495-200464070-00004.
- Background: PubMed 25683732Thomas AC, Wojtys EM, Brandon C, Palmieri-Smith RM. Muscle atrophy contributes to quadriceps weakness after anterior cruciate ligament reconstruction. J Sci Med Sport. 2016 Jan;19(1):7-11. doi: 10.1016/j.jsams.2014.12.009. Epub 2015 Jan 13.
- Background: PubMed 23689765Bauman WA, Spungen AM, Collins JF, Raisch DW, Ho C, Deitrick GA, Nemchausky BA, Goetz LL, Park JS, Schwartz M, Merritt JL, Jayawardena V, Sandford P, Sabharwal S, Holmes SA, Nasar F, Sasaki R, Punj V, Zachow KF, Chua WC, Thomas MD, Trincher RC. The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial. Ann Intern Med. 2013 May 21;158(10):718-26. doi: 10.7326/0003-4819-158-10-201305210-00006.
- Background: PubMed 28840147Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Tauchmann, MD principal investigator
Hospital do Rocio
André Malavasi, MD, PhD study chair
Science Valley
Eduardo Ramacciotti, MD, PhD study director
Science Valley
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxandrolone in people with Anterior Cruciate Ligament (ACL) Reconstruction, run by Science Valley Research Institute at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leandro B Agati, PhD (+55 11 4040-8670, agati@svriglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants experiencing at least one serious adverse event (SAE) over 24-week follow-up period (time frame: From randomization to the end of study on Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974526, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.