Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite AthletesASCEND001NCT07568574
Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes
A study testing Testosterone Enanthate, Testosterone Cypionate and Testosterone Propionate in people with Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes, run by Enhanced Emirates Limited at 1 site in United Arab Emirates.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes
- What is being tested?
- Testosterone Enanthate, Testosterone Cypionate and Testosterone Propionate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 12 Mar 2026to 1 Mar 2033
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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:
- 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.
- Established use (i.e. at least 90 days prior to signing of ICF) of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
- Bilateral tubal occlusion completed at least 90 days prior to signing of ICF.
- 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.
- Sexual abstinence, when this is in line with the preferred and usual lifestyle of the participant.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes: A Hybrid Design in a Real-World Setting
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Testosterone Enanthate, Testosterone Cypionate, Testosterone Propionate, Sustanon (testosterone), Testosterone Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone EnanthateDrug
Intramuscular injection administered for up to 25 weeks
Testosterone CypionateDrug
Intramuscular injection administered for up to 25 weeks
Testosterone PropionateDrug
Intramuscular injection administered for up to 25 weeks
Sustanon (testosterone)Drug
Intramuscular injection administered for up to 25 weeks
Testosterone GelDrug
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 PatchDrug
Topical patch administered for up to 25 weeks
Estradiol CapsuleDrug
Oral capsule administered for up to 25 weeks
Progesterone CreamDrug
Topical cream administered for up to 25 weeks
Progesterone CapsuleDrug
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
MeldoniumDrug
Oral tablet administered for up to 25 weeks
ModafinilDrug
Oral tablet administered for up to 25 weeks
Mixed amphetamine salts (Adderall)Drug
Oral tablet administered for up to 25 weeks
ClomipheneDrug
Ancillary drug: Oral tablet administered as required
AnastrozoleDrug
Ancillary drug: Oral tablet administered as required
LevothyroxineDrug
Ancillary drug: Oral tablet administered as required
LiothyronineDrug
Ancillary drug: Oral tablet administered as required
hCGDrug
Ancillary drug: Subcutaneous injection administered as required
hMGDrug
Ancillary drug: Subcutaneous injection administered as required
AtorvastatinDrug
Ancillary drug: Oral tablet administered as required
RosuvastatinDrug
Ancillary drug: Oral tablet administered as required
BisoprololDrug
Ancillary drug: Oral tablet administered as required
NebivololDrug
Ancillary drug: Oral tablet administered as required
MetoprololDrug
Ancillary drug: Oral tablet administered as required
PropranololDrug
Ancillary drug: Oral tablet administered as required
LisinoprilDrug
Ancillary drug: Oral tablet administered as required
EnalaprilDrug
Ancillary drug: Oral tablet administered as required
FurosemideDrug
Ancillary drug: Oral tablet administered as required
ChlorothiazideDrug
Ancillary drug: Oral tablet administered as required
CabergolineDrug
Ancillary drug: Oral tablet administered as required
MetforminDrug
Ancillary drug: Oral tablet administered as required
Basal Insulin Glargine (long-acting)Drug
Ancillary drug: Subcutaneous injection administered as required
TelmisartanDrug
Ancillary drug: Oral tablet administered as required
LosartanDrug
Ancillary drug: Oral tablet administered as required
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Testosterone Enanthate; Drug: Testosterone Cypionate; Drug: Testosterone Propionate; Drug: Sustanon (testosterone); Drug: Testosterone Gel; Drug: Methenolone Enanthate (Primobolan); Drug: Nandrolone Decanoate (Deca-Durabolin); Drug: Estradiol Patch; Drug: Estradiol Capsule; Drug: Progesterone Cream; Drug: Progesterone Capsule; Drug: Human Growth Hormone (hGH); Drug: EPO Darbepoetin (Aranesp); Drug: Meldonium; Drug: Modafinil; Drug: Mixed amphetamine salts (Adderall); Drug: Clomiphene; Drug: Anastrozole; Drug: Levothyroxine; Drug: Liothyronine; Drug: hCG; Drug: hMG; Drug: Atorvastatin; Drug: Rosuvastatin; Drug: Bisoprolol; Drug: Nebivolol; Drug: Metoprolol; Drug: Propranolol; Drug: Lisinopril; Drug: Enalapril; Drug: Furosemide; Drug: Chlorothiazide; Drug: Cabergoline; Drug: Metformin; Drug: Basal Insulin Glargine (long-acting); Drug: Telmisartan; Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 5.5 years.
The proportion of participants who discontinue PES due to TRAEs.
Measured: Baseline to 5.5 years.
Secondary outcomes (27)
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
Measured: Baseline to week 27, followed by annual assessments until 5.5 years
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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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: %
Measured: 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
Measured: 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: %
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline to week 27
Impact of PES on neurological function (b)
Change from baseline in reaction time and processing speed. Units: milliseconds
Measured: Baseline to week 27
Impact of PES on body composition (a)
Change from baseline in fat distribution. Unit: % of total body weight
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to week 27, followed by ultrasound imaging at years 1, 3, and 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start12 Mar 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite AthletesStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enhanced Emirates Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568574
- Sponsor's protocol ID
- ASCEND001
- Acronym
- ASCEND001
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes: A Hybrid Design in a Real-World Setting
- ClinicalTrials.gov ID
- NCT07568574
- Acronym / sponsor ID
- ASCEND001 / ASCEND001
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Enhanced Emirates LimitedUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Mar 2033 (estimated)
- First posted
- 6 May 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Testosterone Enanthate, Drug: Testosterone Cypionate, Drug: Testosterone Propionate, Drug: Sustanon (testosterone), Drug: Testosterone Gel, Drug: Methenolone Enanthate (Primobolan), Drug: Nandrolone Decanoate (Deca-Durabolin), Drug: Estradiol Patch, Drug: Estradiol Capsule, Drug: Progesterone Cream, Drug: Progesterone Capsule, Drug: Human Growth Hormone (hGH), Drug: EPO Darbepoetin (Aranesp), Drug: Meldonium, Drug: Modafinil, Drug: Mixed amphetamine salts (Adderall), Drug: Clomiphene, Drug: Anastrozole, Drug: Levothyroxine, Drug: Liothyronine, Drug: hCG, Drug: hMG, Drug: Atorvastatin, Drug: Rosuvastatin, Drug: Bisoprolol, Drug: Nebivolol, Drug: Metoprolol, Drug: Propranolol, Drug: Lisinopril, Drug: Enalapril, Drug: Furosemide, Drug: Chlorothiazide, Drug: Cabergoline, Drug: Metformin, Drug: Basal Insulin Glargine (long-acting), Drug: Telmisartan, Drug: LosartanThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (20 listed)
- 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:
- 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.
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 |
|---|---|---|
| Testosterone EnanthateIntramuscular injection administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Testosterone CypionateIntramuscular injection administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Testosterone PropionateIntramuscular injection administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Sustanon (testosterone)Intramuscular injection administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Testosterone GelTopical gel administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Methenolone Enanthate (Primobolan)Intramuscular injection administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Nandrolone Decanoate (Deca-Durabolin)Intramuscular injection administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Estradiol PatchTopical patch administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Estradiol CapsuleOral capsule administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Progesterone CreamTopical cream administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Progesterone CapsuleOral capsule administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Human Growth Hormone (hGH)Subcutaneous injection administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| EPO Darbepoetin (Aranesp)Subcutaneous injection administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| MeldoniumOral tablet administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| ModafinilOral tablet administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Mixed amphetamine salts (Adderall)Oral tablet administered for up to 25 weeks | Drug | Group 2: Enhanced-PES (Intervention Group) |
| ClomipheneAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| AnastrozoleAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| LevothyroxineAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| LiothyronineAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| hCGAncillary drug: Subcutaneous injection administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| hMGAncillary drug: Subcutaneous injection administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| AtorvastatinAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| RosuvastatinAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| BisoprololAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| NebivololAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| MetoprololAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| PropranololAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| LisinoprilAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| EnalaprilAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| FurosemideAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| ChlorothiazideAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| CabergolineAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| MetforminAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| Basal Insulin Glargine (long-acting)Ancillary drug: Subcutaneous injection administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| TelmisartanAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
| LosartanAncillary drug: Oral tablet administered as required | Drug | Group 2: Enhanced-PES (Intervention Group) |
Primary outcome
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.
The proportion of participants who discontinue PES due to TRAEs.
Time frame: Baseline to 5.5 years.
27 secondary outcomes
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
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
Impact of PES on respiratory function and aerobic capacity
Time frame: Baseline to week 27
Impact of PES on blood and urine markers
Time frame: Baseline to 5.5 years.
Impact of PES on cardiac structure and function (a)
Time frame: Baseline to week 27, followed by annual assessments until 5.5 years
Impact of PES on cardiac structure and function (b)
Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.
Impact of PES on cardiac structure and function (c)
Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.
Impact of PES on cardiac structure and function (d)
Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.
Impact of PES on cardiac structure and function (e)
Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.
Impact of PES on cardiac structure and function (f)
Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.
Impact of PES on cardiac structure and function (g)
Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.
Impact of PES on cardiac structure and function (h)
Time frame: Baseline to week 27, followed by annual assessments until 5.5 years.
Impact of PES on cardiac structure and function (i)
Time frame: Baseline with repeat imaging over 5.5 years if clinically indicated.
Impact of PES on cardiac structure and function (j)
Time frame: Baseline with repeat imaging over 5.5 years if clinically indicated.
Impact of PES on neurological function (a)
Time frame: Baseline to week 27
Impact of PES on neurological function (b)
Time frame: Baseline to week 27
Impact of PES on body composition (a)
Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.
Impact of PES on body composition (b)
Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.
Impact of PES on body composition (c)
Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.
Impact of PES on body composition (d)
Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.
Impact of PES on body composition (e)
Time frame: Baseline to week 27, followed by assessments at years 1, 3, and 5 years.
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.
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.
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.
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.
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.
Abdominal, adrenal and thyroid health profiling
Time frame: Baseline to week 27, followed by ultrasound imaging at years 1, 3, and 5 years.
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 6 May 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testosterone Enanthate, Testosterone Cypionate and Testosterone Propionate in people with Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes, run by Enhanced Emirates Limited at 1 site in United Arab Emirates.
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 15 inclusion and 20 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: enrolling by invitation, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.