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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Natural and independently enhanced athletes (Observation Group) | No Intervention | These study participants will either not use any PES (natural) or will use their own PES according to their own schedule (independently enhanced). These participants will not receive any study-provided PES and will have fewer site visits. They will be monitored via a virtual check-in every 4 weeks, primarily to collect safety data. | |
| Group 2: Enhanced-PES (Intervention Group) | Experimental | These study participants will follow one (or more) PES regimens developed by the Sponsor. The study team will work closely with each participant and leverage all available medical and performance data to help plan the optimal PES strategy (or strategies) to ensure safety and tolerability and maximize athletic performance. This study utilizes FDA-approved, market-authorized substances within a prospective, observational case series design and does not constitute a phase-based clinical trial investigation of these products. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Enanthate | Drug | Intramuscular injection administered for up to 25 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 5.5 years. | |
| The proportion of participants who discontinue PES due to TRAEs. | Baseline to 5.5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Baseline to week 27, followed by annual assessments until 5.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of PES on quality of life (QoL) (a) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
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:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Abu Dhabi | United Arab Emirates |
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| 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 |
|
| 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) | Delta in snatch and clean & jerk (Olympic weightlifting total) measured in kilograms | Baseline to week 27, followed by annual assessments until 5.5 years |
| Impact of PES on respiratory function and aerobic capacity | Change from baseline to week 27 in peak oxygen uptake (VO2 max) as measured by graded exercise test, reported in ml/kg/min. | Baseline to week 27 |
| Impact of PES on blood and urine markers | 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). | Baseline to 5.5 years. |
| Impact of PES on cardiac structure and function (a) | Change in left ventricular stroke volume (LV SV) assessed by echocardiogram. Unit: mL/m² | Baseline to week 27, followed by annual assessments until 5.5 years |
| Impact of PES on cardiac structure and function (b) | Change in left ventricular ejection fraction (LVEF) and right ventricular fractional area change (RV FAC) assessed by echocardiagram. Unit: % | Baseline to week 27, followed by annual assessments until 5.5 years. |
| Impact of PES on cardiac structure and function (c) | Change in left ventricular stroke volume (LV SV) and right ventricular stroke volume (RV SV) assessed by CMR imaging. Unit: mL/m² | Baseline to week 27, followed by annual assessments until 5.5 years. |
| Impact of PES on cardiac structure and function (d) | Change in left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) assessed by CMR imaging. Unit: % | Baseline to week 27, followed by annual assessments until 5.5 years. |
| Impact of PES on cardiac structure and function (e) | 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) | Baseline to week 27, followed by annual assessments until 5.5 years. |
| Impact of PES on cardiac structure and function (f) | Number of participants with abnormalities identified on resting 12-lead electrocardiography (ECG). Unit: Number of participants | Baseline to week 27, followed by annual assessments until 5.5 years. |
| Impact of PES on cardiac structure and function (g) | Number of participants with abnormalities identified during exercise stress ECG. Unit: Number of participants | Baseline to week 27, followed by annual assessments until 5.5 years. |
| Impact of PES on cardiac structure and function (h) | Number of participants with abnormalities identified during 24-hour ambulatory ECG monitoring. Unit: Number of participants | Baseline to week 27, followed by annual assessments until 5.5 years. |
| Impact of PES on cardiac structure and function (i) | Coronary artery calcium score assessed by cardiac computed tomography (CT). Unit: Agatston score (AU), categorised as 0, 1-10, 11-100, 101-400, >400 | Baseline with repeat imaging over 5.5 years if clinically indicated. |
| Impact of PES on cardiac structure and function (j) | Changes in participant qualitative description of coronary atherosclerosis assessed by cardiac computed tomography (CT). Unit: Delta in clinical abnormalities | Baseline with repeat imaging over 5.5 years if clinically indicated. |
| Impact of PES on neurological function (a) | Change from baseline in cognitive memory performance (composite score of correct responses) | Baseline to week 27 |
| Impact of PES on neurological function (b) | Change from baseline in reaction time and processing speed. Units: milliseconds | Baseline to week 27 |
| Impact of PES on body composition (a) | Change from baseline in fat distribution. Unit: % of total body weight | Baseline to week 27, followed by assessments at years 1, 3, and 5 years. |
| Impact of PES on body composition (b) | Change from baseline in bone mineral density at key sites (lumbar spine and hip). Unit: Z-score | Baseline to week 27, followed by assessments at years 1, 3, and 5 years. |
| Impact of PES on body composition (c) | Change from baseline in landmark-based limb girth measurements (upper arm, thigh, calf) assessed by anthropometry. Unit: cm | Baseline to week 27, followed by assessments at years 1, 3, and 5 years. |
| Impact of PES on body composition (d) | Change from baseline in body water distribution, including extracellular water (ECW), intracellular water (ICW), and total body water (TBW). Unit: Litres (L) | Baseline to week 27, followed by assessments at years 1, 3, and 5 years. |
| Impact of PES on body composition (e) | Change from baseline in body mass index (BMI). Unit: kg/m² | Baseline to week 27, followed by assessments at years 1, 3, and 5 years. |
| Impact of PES on musculoskeletal composition, function and strength (a) | Change from baseline in cross-sectional area (CSA) of hip flexors and extensors assessed by MRI. Unit: cm² | Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years. |
| Impact of PES on musculoskeletal composition, function and strength (b) | Change from baseline in total muscle volume assessed by segmentation-based MRI analysis. Unit: cm³ | Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years. |
| Impact of PES on musculoskeletal composition, function and strength (c) | Change from baseline in muscle thickness and shape assessed by MRI. Unit: mm | Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years. |
| Impact of PES on musculoskeletal composition, function and strength (d) | Change from baseline in grip strength. Unit: Newtons | Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years. |
| Impact of PES on musculoskeletal composition, function and strength (e) | Incidence of musculoskeletal injuries throughout study duration. Unit: Number of events | Baseline to week 27, followed by musculoskeletal composition imaging at years 1, 3, and 5 years. |
| Abdominal, adrenal and thyroid health profiling | 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 | Baseline to week 27, followed by ultrasound imaging at years 1, 3, and 5 years. |
| Impact of PES on quality of life (QoL) (b) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (c) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (d) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (e) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (f) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (g) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (h) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (i) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (j) | 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 | Baseline to week 27 |
| Impact of PES on quality of life (QoL) (k) | 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 | Baseline to week 27 |
| Impact of PES on quality of life (QoL) (l) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on quality of life (QoL) (m) | 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 | Week 27 to 6-month follow-up |
| Impact of PES on physiological-lifestyle metrics (sleep, physical activity, stress levels and cardiovascular function) using continuous monitoring technologies (a) | Change from baseline in sleep quality assessed by total sleep duration using Polar360 continuous monitoring technology. Unit: Minutes per night | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on physiological-lifestyle metrics (sleep, physical activity, stress levels and cardiovascular function) using continuous monitoring technologies (b) | Change from baseline in total daily energy expenditure using Polar360 continuous monitoring technology. Unit: Kilocalories (kcal) | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on physiological-lifestyle metrics (sleep, physical activity, stress levels and cardiovascular function) using continuous monitoring technologies (c) | Change from baseline in recovery score assessed by heart rate variability using Polar360 continuous monitoring technology. Unit: Milliseconds (ms) | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on transcriptomic, proteomic and metabolomic biomarkers | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on musculoskeletal function and tissue integrity (a) | Change from baseline in cardiorespiratory fitness assessed by maximal exercise test performance. Unit: mL/kg/min (VO₂max) | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on musculoskeletal function and tissue integrity (b) | 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) | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on musculoskeletal function and tissue integrity (c) | 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 | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Effect of PES on hemoglobin mass | Change in total circulating hemoglobin mass based on carboxyhemoglobin (COHb) dilution and the CO inhaled from baseline to week 27. | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on lung function (a) | 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) | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on lung function (b) | Change from baseline in FEV1/FVC ratio assessed by spirometry. Unit: Ratio | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| Impact of PES on lung function (c) | 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) | Baseline to week 27, followed by annual assessments up to 5.5 years. |
| ID | Term |
|---|---|
| C004648 | testosterone enanthate |
| C016131 | testosterone 17 beta-cypionate |
| D043343 | Testosterone Propionate |
| D013739 | Testosterone |
| C028758 | methenolone enanthate |
| C033244 | methenolone acetate |
| D000077603 | Nandrolone Decanoate |
| D009277 | Nandrolone |
| C511292 | Ortho Evra |
| D004958 | Estradiol |
| D011374 | Progesterone |
| D019382 | Human Growth Hormone |
| D000068256 | Darbepoetin alfa |
| C050147 | 3-(2,2,2-trimethylhydrazine)propionate |
| D000077408 | Modafinil |
| C090411 | Adderall |
| D002996 | Clomiphene |
| D000077384 | Anastrozole |
| D013974 | Thyroxine |
| D014284 | Triiodothyronine |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| D017298 | Bisoprolol |
| D000068577 | Nebivolol |
| D008790 | Metoprolol |
| D011433 | Propranolol |
| D017706 | Lisinopril |
| D004656 | Enalapril |
| D005665 | Furosemide |
| D002740 | Chlorothiazide |
| D000077465 | Cabergoline |
| D008687 | Metformin |
| D000077333 | Telmisartan |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004963 | Estrenes |
| D004962 | Estranes |
| D045166 | Estradiol Congeners |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013963 | Thyroid Hormones |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D013970 | Thyronines |
| D011758 | Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D001581 | Benzothiadiazines |
| D049971 | Thiazides |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D001713 | Biphenyl Compounds |
| D001562 | Benzimidazoles |
| D007093 | Imidazoles |
| D013777 | Tetrazoles |
Not provided
Not provided