RecruitingNot Applicable

Prospective, Longitudinal Study on FItness DOping in DenmarK

Denmark900 participantsStarted 2022-06-14

Plain-language summary

The aim of this prospective longitudinal study is to investigate the risks associated with use of anabolic steroids in fitness circles in Denmark in order to assess the scope of therapeutic need existing as a consequence of use. The objectives are: * To assess long-term complications and outcomes related to: cardiovascular disease, diabetes, gonadal disease (women and men) and psychiatric disease using data from Danish registries including addressing central questions such as whether the following characteristics play a role for development of overt disease * Characterization of illicit AAS use among men and women * Current male reproductive health * Current psychological well-being, aggressive tendencies, cognitive function and quality of life * Current cardiovascular and metabolic status The participants will undergo: * Semi-structured medical interview * Physical examinations * Questionnaires * Blood and urine sampling * Dual X-ray Absorptiometry With a subset undergoing further testing, including semen analysis, gonadotropin-releasing hormone (GnRH) and human chorionic gonadotropinm (hCG) stimulation and 82Rubidium positron emission tomography and computer tomography (PET/CT). Register-based follow-up is planned every third year until the 15th year, marking the completion of the trial. The study will include 800 participants with current or former AAS use and 100 participants (80 male; 20 female) as controls with no former or current use of AAS.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Male and female recreational athletes (≥18 years of age) with current or former illicit use (\>3 months since AAS cessation) of PIEDs (e.g. AAS) for a minimum four weeks Inclusion Criteria (Controls, n = 100): \- Male (n=80) or female (n=20) recreational athletes (≥18 years of age) with NO current or former illicit use of AAS. Exclusion Criteria: * Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program. * Known pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiovascular composite endpoint

Timeframe: 15 years

Trial details

NCT IDNCT05599438

SponsorCaroline Michaela Kistorp

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-01

Contact for this trial

Caroline M Kistorp, Professor

004535459642 caroline.michaela.kistorp@regionh.dk

View on ClinicalTrials.gov More Anabolic Steroid Overdose trials