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

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. 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.

Conditions

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

Interventions

DRUG

Testosterone Enanthate

Intramuscular injection administered for up to 25 weeks

DRUG

Testosterone Cypionate

Intramuscular injection administered for up to 25 weeks

DRUG

Testosterone Propionate

Intramuscular injection administered for up to 25 weeks

DRUG

Sustanon (testosterone)

Intramuscular injection administered for up to 25 weeks

DRUG

Testosterone Gel

Topical gel administered for up to 25 weeks

DRUG

Methenolone Enanthate (Primobolan)

Intramuscular injection administered for up to 25 weeks

DRUG

Nandrolone Decanoate (Deca-Durabolin)

Intramuscular injection administered for up to 25 weeks

DRUG

Estradiol Patch

Topical patch administered for up to 25 weeks

DRUG

Estradiol Capsule

Oral capsule administered for up to 25 weeks

DRUG

Progesterone Cream

Topical cream administered for up to 25 weeks

DRUG

Progesterone Capsule

Oral capsule administered for up to 25 weeks

DRUG

Human Growth Hormone (hGH)

Subcutaneous injection administered for up to 25 weeks

DRUG

EPO Darbepoetin (Aranesp)

Subcutaneous injection administered for up to 25 weeks

DRUG

Meldonium

Oral tablet administered for up to 25 weeks

DRUG

Modafinil

Oral tablet administered for up to 25 weeks

DRUG

Mixed amphetamine salts (Adderall)

Oral tablet administered for up to 25 weeks

DRUG

Clomiphene

Ancillary drug: Oral tablet administered as required

DRUG

Anastrozole

Ancillary drug: Oral tablet administered as required

DRUG

Levothyroxine

Ancillary drug: Oral tablet administered as required

DRUG

Liothyronine

Ancillary drug: Oral tablet administered as required

DRUG

hCG

Ancillary drug: Subcutaneous injection administered as required

DRUG

hMG

Ancillary drug: Subcutaneous injection administered as required

DRUG

Atorvastatin

Ancillary drug: Oral tablet administered as required

DRUG

Rosuvastatin

Ancillary drug: Oral tablet administered as required

DRUG

Bisoprolol

Ancillary drug: Oral tablet administered as required

DRUG

Nebivolol

Ancillary drug: Oral tablet administered as required

DRUG

Metoprolol

Ancillary drug: Oral tablet administered as required

DRUG

Propranolol

Ancillary drug: Oral tablet administered as required

DRUG

Lisinopril

Ancillary drug: Oral tablet administered as required

DRUG

Enalapril

Ancillary drug: Oral tablet administered as required

DRUG

Furosemide

Ancillary drug: Oral tablet administered as required

DRUG

Chlorothiazide

Ancillary drug: Oral tablet administered as required

DRUG

Cabergoline

Ancillary drug: Oral tablet administered as required

DRUG

Metformin

Ancillary drug: Oral tablet administered as required

DRUG

Basal Insulin Glargine (long-acting)

Ancillary drug: Subcutaneous injection administered as required

DRUG

Telmisartan

Ancillary drug: Oral tablet administered as required

DRUG

Losartan

Ancillary drug: Oral tablet administered as required

Sponsors & Collaborators

• Enhanced Emirates Limited

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-12

Primary Completion

2028-05-01

Completion

2033-03-01

Countries

• United Arab Emirates

Study Locations