Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes
ASCEND001
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2026
CompletedFirst Submitted
Initial submission to the registry
April 17, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2033
May 6, 2026
April 1, 2026
2.1 years
April 17, 2026
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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)
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)
Baseline to week 27, followed by annual assessments until 5.5 years
Impact of PES on respiratory function and aerobic capacity
Baseline to week 27
Impact of PES on blood and urine markers
Baseline to 5.5 years.
Impact of PES on cardiac structure and function (a)
Baseline to week 27, followed by annual assessments until 5.5 years
- +22 more secondary outcomes
Other Outcomes (24)
Impact of PES on quality of life (QoL) (a)
Baseline to week 27, followed by annual assessments up to 5.5 years.
Impact of PES on quality of life (QoL) (b)
Baseline to week 27, followed by annual assessments up to 5.5 years.
Impact of PES on quality of life (QoL) (c)
Baseline to week 27, followed by annual assessments up to 5.5 years.
- +21 more other outcomes
Study Arms (2)
Group 1: Natural and independently enhanced athletes (Observation Group)
NO INTERVENTIONThese 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)
EXPERIMENTALThese 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.
Interventions
Intramuscular injection administered for up to 25 weeks
Intramuscular injection administered for up to 25 weeks
Intramuscular injection administered for up to 25 weeks
Intramuscular injection administered for up to 25 weeks
Topical gel administered for up to 25 weeks
Topical patch administered for up to 25 weeks
Oral capsule administered for up to 25 weeks
Subcutaneous injection administered for up to 25 weeks
Subcutaneous injection administered for up to 25 weeks
Oral tablet administered for up to 25 weeks
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Subcutaneous injection administered as required
Ancillary drug: Subcutaneous injection administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Intramuscular injection administered for up to 25 weeks
Intramuscular injection administered for up to 25 weeks
Oral capsule administered for up to 25 weeks
Topical cream administered for up to 25 weeks
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Oral tablet administered as required
Ancillary drug: Subcutaneous injection administered as required
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Site
Abu Dhabi, United Arab Emirates
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2026
First Posted
May 6, 2026
Study Start
March 12, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
March 1, 2033
Last Updated
May 6, 2026
Record last verified: 2026-04