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NCT Number: NCT07568574

Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes

Objectives:

The primary objective is to assess the safety and tolerability of medical drugs with the potential to enhance performance (PES) in professional athletes over a 5.5 year period, encompassing a 25-week PES Exposure period and 5 year long term follow-up of period comprehensive health and safety monitoring. The secondary objective is to evaluate the impact of PES on athletic performance through validated sport specific and clinical assessments.

Methods:

This prospective hybrid design study will enrol 60 adult participants, divided into two groups. The first group will receive performance-enhancing substances (PES) directly through the study, administered as Investigational Medicinal Products (IMPs) under comprehensive medical supervision for up to 25 weeks. The second group will include natural athletes and those already using PES prescribed by their own doctors. All substances used in this study are medically approved by national regulatory agencies (e.g., FDA, MHRA, EMA, EDE, etc.), and market authorised.

Participants undergo enrollment and baseline health and performance assessments, prior to a 25 weeks of PES exposure. During the period of PES exposure, participants undergo periodic monitoring of comprehensive physiological biomarkers alongside subjective assessments. Following the PES exposure phase, participants will complete repeat baseline health and performance assessments, followed by a titration phase and, where indicated, post-cycle therapy (PCT) to support the restoration of physiological function toward baseline. The study will conclude with a five-year longitudinal follow-up period to monitor long-term health outcomes. During this phase, participants will undergo annual assessments, including cardiac electrocardiography (ECG), echocardiography, magnetic resonance imaging (MRI), blood and urine biomarkers, routine vital signs, and quality-of-life measures. Additional imaging will include brain functional MRI (fMRI) and vital organ ultrasound at years 1, 3, and 5, with cardiac CT performed as clinically indicated. Athlete safety biomarker assessments, clinical evaluations, and adverse event reporting, will be continuously evaluated by study doctors and with additional safety oversight from a Data Safety Monitoring Board, Independent Medical Commission (a multidisciplinary panel of medical experts), and a Medical Monitor.

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Key information

Conditions

Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Site

Abu Dhabi, United Arab Emirates

About this study

This study employs a prospective hybrid design comprising an observational cohort alongside a non-randomised interventional cohort, allowing for individualized PES regimens, biomarker-informed adaptation, and alignment with each athlete's training cycle while providing for the first time prospective data on safety parameters and performance effects of PES. It emphasizes within-subject change over time rather than between-group comparisons, offering a more ecologically valid framework for observing enhancement in context. Participants will continue periodized training while under continuous monitoring, enabling assessment of both physiological response and performance progression under real-world conditions. Similar study designs that aim to determine optimal therapy customization to individuals with specific biomarkers are becoming increasingly popular in precision medicine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants are eligible to be included in the study only if all the following criteria apply:

  • Participant must be 18 years of age or older at the time of signing the informed consent.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • For a participant that intends to and uses PES as part of the study, the participant must be retired from professional sporting organizations that prohibit the performance enhancing substances and substances studied and must not be subject to active anti-doping regulations or testing pools at the time of enrollment.
  • Participant must be under the care of a primary care provider (PCP).
  • Participant passes medical profiling assessment (measuring overall state of health and quality of life)
  • Females must meet one of the following:
  • Postmenopausal (>45 years of age with amenorrhea for at least 12 months, without using exogenous hormonal contraception and with FSH ≥ 40 IU/L).
  • Surgically sterile (hysterectomy, bilateral salpingectomy; oophorectomy) for at least 6 months.
  • Using a double contraception including a barrier method (condom, diaphragm, or occlusive cap) and a highly effective method of birth control, which includes the following:

i. Established use (i.e. at least 90 days prior to signing of ICF) of combined (estrogen and progestogen) oral, intravaginal, or transdermal hormonal contraceptive associated with inhibition of ovulation. ii. Established use (i.e. at least 90 days prior to signing of ICF) of progestogen- only oral, injectable, or implantable hormonal contraceptive associated with inhibition of ovulation.

iii. Established use (i.e. at least 90 days prior to signing of ICF) of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).

iv. Bilateral tubal occlusion completed at least 90 days prior to signing of ICF.

d) Vasectomized partner with the appropriate post-vasectomy documentation of the absence of spermatozoa in the ejaculate. Participant must provide documentation before the first dose of PES.

e) Sexual abstinence, when this is in line with the preferred and usual lifestyle of the participant.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

  • A self-reported history of any significant psychological or psychiatric challenges that may affect their ability to safely engage in the study or comply with study procedures. This includes, but is not limited to:
  • Ongoing or recently unstable conditions such as severe depression or other psychiatric disorders that have not been effectively managed, in the judgement of the clinical research team.
  • A history of severe mental health conditions (e.g., schizophrenia, bipolar disorder) that have required intensive intervention or hospitalization within the past 5 years.
  • Prior history of malignancy (including breast cancer, lymphoma, leukemia) within the past 5 years except for cervical or prostate carcinoma in situ that has been completely resected or cured basal or squamous cell skin carcinoma.
  • Has a history of CV disease that includes any of the following:
  • Unstable CV disease, myocardial infarction, unstable angina, cardiac bypass or coronary arteries stenting, cerebrovascular accident (stroke), or transient ischemic attack.
  • Clinically significant cardiac arrhythmias, including congenital arrhythmia syndromes (e.g. Long QT syndrome, Brugada Syndrome) or acquired arrhythmias, including pacemaker or ICD.

Note. Cases will be considered on a case-by-case basis following an expert sports cardiology review using the newest internationally published recommendations.

  • Congestive heart failure (New York Heart Association class II to IV symptoms) or inherited or acquired cardiomyopathies Note. Cases will be considered on a case-by-case basis following an expert sports cardiology review using the newest internationally published recommendations.
  • Current or history of clinically significant (per Investigator's judgment) liver or biliary disease.
  • Current acute or chronic self-reported HCV and/or HBV infection.
  • Current or history of clinically significant renal disease (per Investigator's judgment) or GFR <60mL/min/1.73m2
  • Has history or presence of any results from Screening Visit laboratory tests, ECG, physical examination, or vital signs that, in the opinion of the Investigator, Medical Monitor, or Sponsor, should be exclusionary for such a candidate.
  • The use of other investigational drugs at the time of screening or within 30 days or 5 half- lives prior to signing of the ICF, whichever is longer, or longer if required by local regulations.

Note. Upon entry into the long-term follow-up phase of the study, participation in another clinical trial may be permitted only if it does not interfere with the objectives of this study. This is at the discretion of the study Investigator.

  • Pregnant or breastfeeding.
  • Has a mental or legal incapacity.
  • Is unwilling to provide written informed consent or is unable to follow the procedures outlined in the Protocol.

Prospective approval of protocol deviations to recruitment and eligibility criteria, also known as protocol waivers or exemptions, is not permitted.

Treatment and study plan

Testosterone Enanthate

Drug

Intramuscular injection administered for up to 25 weeks

Testosterone Cypionate

Drug

Intramuscular injection administered for up to 25 weeks

testosterone propionate

Drug

Intramuscular injection administered for up to 25 weeks

Sustanon (testosterone)

Drug

Intramuscular injection administered for up to 25 weeks

Testosterone gel

Drug

Topical gel administered for up to 25 weeks

Methenolone Enanthate (Primobolan)

Drug

Intramuscular injection administered for up to 25 weeks

Nandrolone Decanoate (Deca-Durabolin)

Drug

Intramuscular injection administered for up to 25 weeks

Estradiol patch

Drug

Topical patch administered for up to 25 weeks

Estradiol Capsule

Drug

Oral capsule administered for up to 25 weeks

Progesterone Cream

Drug

Topical cream administered for up to 25 weeks

Progesterone Capsule

Drug

Oral capsule administered for up to 25 weeks

Human Growth Hormone (hGH)

Drug

Subcutaneous injection administered for up to 25 weeks

EPO Darbepoetin (Aranesp)

Drug

Subcutaneous injection administered for up to 25 weeks

Meldonium

Drug

Oral tablet administered for up to 25 weeks

Modafinil

Drug

Oral tablet administered for up to 25 weeks

Mixed amphetamine salts (Adderall)

Drug

Oral tablet administered for up to 25 weeks

Clomiphene

Drug

Ancillary drug: Oral tablet administered as required

Anastrozole

Drug

Ancillary drug: Oral tablet administered as required

Levothyroxine

Drug

Ancillary drug: Oral tablet administered as required

liothyronine

Drug

Ancillary drug: Oral tablet administered as required

HCG

Drug

Ancillary drug: Subcutaneous injection administered as required

hMG

Drug

Ancillary drug: Subcutaneous injection administered as required

atorvastatin

Drug

Ancillary drug: Oral tablet administered as required

Rosuvastatin

Drug

Ancillary drug: Oral tablet administered as required

Bisoprolol

Drug

Ancillary drug: Oral tablet administered as required

nebivolol

Drug

Ancillary drug: Oral tablet administered as required

metoprolol

Drug

Ancillary drug: Oral tablet administered as required

Propranolol

Drug

Ancillary drug: Oral tablet administered as required

Lisinopril

Drug

Ancillary drug: Oral tablet administered as required

Enalapril

Drug

Ancillary drug: Oral tablet administered as required

Furosemide

Drug

Ancillary drug: Oral tablet administered as required

chlorothiazide

Drug

Ancillary drug: Oral tablet administered as required

cabergoline

Drug

Ancillary drug: Oral tablet administered as required

metformin

Drug

Ancillary drug: Oral tablet administered as required

Basal Insulin Glargine (long-acting)

Drug

Ancillary drug: Subcutaneous injection administered as required

Telmisartan

Drug

Ancillary drug: Oral tablet administered as required

Losartan

Drug

Ancillary drug: Oral tablet administered as required

Primary outcomes

  1. The incidence and severity of Treatment-related adverse events (TRAEs), including adverse events (AEs) and serious adverse events (SAEs), as assessed by the study physicians from baseline to 5.5 years after enrollment.

    Time frame: Baseline to 5.5 years.

  2. The proportion of participants who discontinue PES due to TRAEs.

    Time frame: Baseline to 5.5 years.

Secondary outcomes

  1. Changes in sport-specific performance metrics, tailored to the athlete's discipline, in order to assess how individualized PES regimens translate into functional outcomes relevant to each sport (a)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years

    Delta in 100-meter track sprint time, 50-meter freestyle swim time, 100-meter freestyle swim time, 50-meter butterfly swim time, and 100-meter butterfly swim time, measured in seconds

  2. Changes in sport-specific performance metrics, tailored to the athlete's discipline, in order to assess how individualized PES regimens translate into functional outcomes relevant to each sport (b)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years

    Delta in snatch and clean & jerk (Olympic weightlifting total) measured in kilograms

  3. Impact of PES on respiratory function and aerobic capacity

    Time frame: Baseline to week 27

    Change from baseline to week 27 in peak oxygen uptake (VO2 max) as measured by graded exercise test, reported in ml/kg/min.

  4. Impact of PES on blood and urine markers

    Time frame: Baseline to 5.5 years.

    Number of participants with abnormal laboratory tests results.

    Measured from baseline through 5.5 years comprising up to 25 week PES exposure followed by a 5-year annual longitudinal follow-up. Markers include oxygen transport and immune system balance (CBC with 5-part differential); organ function and metabolic stress (comprehensive metabolic panel); iron status and oxygen-carrying capacity (serum iron, ferritin, transferrin saturation, TIBC); cardiovascular health and lipid metabolism (HDL, LDL, VLDL, triglycerides, Apo A1/B, lipoprotein(a)); hormonal balance and endocrine resilience (testosterone, estrogen, cortisol, DHEA, TSH, T3, T4, LH, FSH, prolactin); electrolyte and hydration balance (sodium, potassium, calcium, magnesium, chloride); systemic inflammation and immune activation (hs-CRP, ferritin, alpha-1 antitrypsin); and fatty acid profile and cellular membrane health (omega-3/omega-6 balance, EPA/DHA ratio, arachidonic acid).

  5. Impact of PES on cardiac structure and function (a)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years

    Change in left ventricular stroke volume (LV SV) assessed by echocardiogram. Unit: mL/m²

  6. Impact of PES on cardiac structure and function (b)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.

    Change in left ventricular ejection fraction (LVEF) and right ventricular fractional area change (RV FAC) assessed by echocardiagram.

    Unit: %

  7. Impact of PES on cardiac structure and function (c)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.

    Change in left ventricular stroke volume (LV SV) and right ventricular stroke volume (RV SV) assessed by CMR imaging.

    Unit: mL/m²

  8. Impact of PES on cardiac structure and function (d)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.

    Change in left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) assessed by CMR imaging.

    Unit: %

  9. Impact of PES on cardiac structure and function (e)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.

    Qualitative assessment of left and right ventricular myocardial fibrosis by location and extent using late gadolinium enhancement (LGE) on CMR imaging.

    Unit: Qualitative description (location and extent of fibrosis)

  10. Impact of PES on cardiac structure and function (f)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.

    Number of participants with abnormalities identified on resting 12-lead electrocardiography (ECG).

    Unit: Number of participants

  11. Impact of PES on cardiac structure and function (g)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.

    Number of participants with abnormalities identified during exercise stress ECG.

    Unit: Number of participants

  12. Impact of PES on cardiac structure and function (h)

    Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.

    Number of participants with abnormalities identified during 24-hour ambulatory ECG monitoring.

    Unit: Number of participants

  13. Impact of PES on cardiac structure and function (i)

    Time frame: Baseline with repeat imaging over 5.5 years if clinically indicated.

    Coronary artery calcium score assessed by cardiac computed tomography (CT). Unit: Agatston score (AU), categorised as 0, 1-10, 11-100, 101-400, >400

  14. Impact of PES on cardiac structure and function (j)

    Time frame: Baseline with repeat imaging over 5.5 years if clinically indicated.

    Changes in participant qualitative description of coronary atherosclerosis assessed by cardiac computed tomography (CT).

    Unit: Delta in clinical abnormalities

  15. Impact of PES on neurological function (a)

    Time frame: Baseline to week 27

    Change from baseline in cognitive memory performance (composite score of correct responses)

  16. Impact of PES on neurological function (b)

    Time frame: Baseline to week 27

    Change from baseline in reaction time and processing speed. Units: milliseconds

  17. Impact of PES on body composition (a)

    Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.

    Change from baseline in fat distribution. Unit: % of total body weight

  18. Impact of PES on body composition (b)

    Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.

    Change from baseline in bone mineral density at key sites (lumbar spine and hip). Unit: Z-score

  19. Impact of PES on body composition (c)

    Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.

    Change from baseline in landmark-based limb girth measurements (upper arm, thigh, calf) assessed by anthropometry.

    Unit: cm

  20. Impact of PES on body composition (d)

    Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.

    Change from baseline in body water distribution, including extracellular water (ECW), intracellular water (ICW), and total body water (TBW).

    Unit: Litres (L)

  21. Impact of PES on body composition (e)

    Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.

    Change from baseline in body mass index (BMI). Unit: kg/m²

  22. Impact of PES on musculoskeletal composition, function and strength (a)

    Time frame: Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years.

    Change from baseline in cross-sectional area (CSA) of hip flexors and extensors assessed by MRI. Unit: cm²

  23. Impact of PES on musculoskeletal composition, function and strength (b)

    Time frame: Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years.

    Change from baseline in total muscle volume assessed by segmentation-based MRI analysis. Unit: cm³

  24. Impact of PES on musculoskeletal composition, function and strength (c)

    Time frame: Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years.

    Change from baseline in muscle thickness and shape assessed by MRI. Unit: mm

  25. Impact of PES on musculoskeletal composition, function and strength (d)

    Time frame: Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years.

    Change from baseline in grip strength. Unit: Newtons

  26. Impact of PES on musculoskeletal composition, function and strength (e)

    Time frame: Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years.

    Incidence of musculoskeletal injuries throughout study duration. Unit: Number of events

  27. Abdominal, adrenal and thyroid health profiling

    Time frame: Baseline to week 27, followed by ultrasound imaging at years 1, 3, and 5 years.

    Number of participants with abnormal clinical findings on abdominal, adrenal, and thyroid imaging (ultrasound), including abnormalities of organ size and structure (liver, kidneys, pancreas, spleen, gallbladder, bile ducts, adrenal glands, thyroid glands), tears, hernias, and pathological findings such as tumours, nodules, cysts, aneurysms, thrombosis, or inflammation.

    Unit: Number of participants

Other outcomes

  1. Impact of PES on quality of life (QoL) (a)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the Generalized Anxiety Disorder 7-item scale (GAD-7), measuring severity of generalized anxiety. Scores range from 0 to 21, with higher scores indicating greater anxiety severity.

    Unit: Units on a scale

  2. Impact of PES on quality of life (QoL) (b)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the Patient Health Questionnaire 9-item scale (PHQ-9), measuring severity of depression. Scores range from 0 to 27, with higher scores indicating greater depression severity.

    Unit: Units on a scale

  3. Impact of PES on quality of life (QoL) (c)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the Athlete Burnout Questionnaire (ABQ). Scores range from 1 to 5, with higher scores indicating greater burnout.

    Unit: Units on a scale

  4. Impact of PES on quality of life (QoL) (d)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the PERMA Profiler, measuring well-being across five domains (positive emotion, engagement, relationships, meaning, and accomplishment). Scores range from 0 to 10, with higher scores indicating greater well-being.

    Unit: Units on a scale

  5. Impact of PES on quality of life (QoL) (e)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the Athlete Sleep Screening Questionnaire (ASSQ), measuring sleep habits and quality of sleep. Scores range from 0 to 17, with higher scores indicating greater sleep disturbance.

    Unit: Units on a scale

  6. Impact of PES on quality of life (QoL) (f)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the Hooper Questionnaire, measuring indicators of overtraining in athletes. Scores range from 4 to 28, with higher scores indicating greater overtraining burden.

    Unit: Units on a scale

  7. Impact of PES on quality of life (QoL) (g)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the Big Five TIPI measuring personality traits. Scores range from 1 to 7 per domain, with higher scores indicating greater expression of each trait. Unit: Units on a scale

  8. Impact of PES on quality of life (QoL) (h)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the HEXACO questionnaire, measuring personality traits. Scores range from 1 to 5 per domain, with higher scores indicating greater expression of each trait. Unit: Units on a scale

  9. Impact of PES on quality of life (QoL) (i)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the Sport Mental Health Assessment Tool 1 (SMHAT-1), an IOC mental health screening tool. Scores range from 10 to 50, with higher scores indicating greater psychological distress. Unit: Units on a scale

  10. Impact of PES on quality of life (QoL) (j)

    Time frame: Baseline to week 27

    Change from baseline in score on the RT18 questionnaire, measuring risk-taking behaviour. Scores range from 0 to 18, with higher scores indicating greater risk-taking propensity. Unit: Units on a scale

  11. Impact of PES on quality of life (QoL) (k)

    Time frame: Baseline to week 27

    Change from baseline in score on RISQ questionnaire, measuring risk-taking behaviours. Scores range from 0 to 38, with higher scores indicating a greater number of endorsed risk behaviours. Unit: Units on a scale

  12. Impact of PES on quality of life (QoL) (l)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in score on the Total Quality of Recovery (TQR) scale, measuring perceived athlete recovery. Scores range from 6 to 20, with higher scores indicating better perceived recovery. Unit: Units on a scale

  13. Impact of PES on quality of life (QoL) (m)

    Time frame: Week 27 to 6-month follow-up

    Change from week 27 in score on the Severity of Dependence Scale (SDS), measuring psychological dependence. Scores range from 0 to 15, with higher scores indicating greater psychological dependence. Unit: Units on a scale

  14. Impact of PES on physiological-lifestyle metrics (sleep, physical activity, stress levels and cardiovascular function) using continuous monitoring technologies (a)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in sleep quality assessed by total sleep duration using Polar360 continuous monitoring technology. Unit: Minutes per night

  15. Impact of PES on physiological-lifestyle metrics (sleep, physical activity, stress levels and cardiovascular function) using continuous monitoring technologies (b)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in total daily energy expenditure using Polar360 continuous monitoring technology. Unit: Kilocalories (kcal)

  16. Impact of PES on physiological-lifestyle metrics (sleep, physical activity, stress levels and cardiovascular function) using continuous monitoring technologies (c)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in recovery score assessed by heart rate variability using Polar360 continuous monitoring technology. Unit: Milliseconds (ms)

  17. Impact of PES on transcriptomic, proteomic and metabolomic biomarkers

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Number of participants with changes in the following laboratory tests results. Markers measured include gene expression patterns (transcriptomics) associated with inflammation, metabolic regulation, and recovery status; circulating protein biomarkers (proteomics) linked to muscle remodeling, immune activation, hormonal signaling, known and novel biomarkers of exogenous PES use; change in metabolite profiles (metabolomics) involved in energy system utilization, oxidative stress, nutritional adaptation, and known and novel biomarkers of exogenous PES use

  18. Impact of PES on musculoskeletal function and tissue integrity (a)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in cardiorespiratory fitness assessed by maximal exercise test performance. Unit: mL/kg/min (VO₂max)

  19. Impact of PES on musculoskeletal function and tissue integrity (b)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in force generation assessed by strength tests, including standing broad jump, standing overhead medicine ball throw, isometric mid-thigh pull, peak torque of quadriceps and hamstrings, hamstring-to-quadriceps strength ratio, and bilateral symmetry index. Unit: Newtons (N)

  20. Impact of PES on musculoskeletal function and tissue integrity (c)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Number of participants with muscle-tendon architecture abnormal clinical values, assessed by ultrasound of Achilles and patellar tendons (morphology, tissue composition, structural integrity, elasticity, and mechanical properties) and skeletal muscle (muscle thickness, cross-sectional area, pennation angle, fascicle length, echo intensity, and Doppler vascularity). Unit: Number of participants

  21. Effect of PES on hemoglobin mass

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change in total circulating hemoglobin mass based on carboxyhemoglobin (COHb) dilution and the CO inhaled from baseline to week 27.

  22. Impact of PES on lung function (a)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in pulmonary volumes assessed by spirometry, including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), inspiratory vital capacity (IVC), slow vital capacity (SVC), expiratory reserve volume (ERV), and tidal volume (TV). Unit: Litres (L)

  23. Impact of PES on lung function (b)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in FEV1/FVC ratio assessed by spirometry. Unit: Ratio

  24. Impact of PES on lung function (c)

    Time frame: Baseline to week 27, followed by annual assessments up to 5.5 years.

    Change from baseline in airflow rates assessed by spirometry, including peak expiratory flow (PEF), forced expiratory flow at 25-75% of FVC (FEF25-75%), and maximal voluntary ventilation (MVV). Unit: Litres per minute (L/min)

Sponsors and collaborators

Lead sponsor

Enhanced Emirates Limited

Other

Registry information

Official study title

Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes: A Hybrid Design in a Real-World Setting

Acronym: ASCEND001

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.