NCT05599438 Prospective, Longitudinal Study on FItness DOping in DenmarK
| NCT ID | NCT05599438 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Caroline Michaela Kistorp |
| Condition | Anabolic Steroid Overdose |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2022-06-14 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2022-06-14 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Caroline M Kistorp, Professor
PRINCIPAL INVESTIGATOR
Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet
Frequently Asked Questions
Who can join the NCT05599438 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anabolic Steroid Overdose. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05599438 currently recruiting?
Yes, NCT05599438 is actively recruiting participants. Contact the research team at caroline.michaela.kistorp@regionh.dk for enrollment information.
Where is the NCT05599438 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05599438 clinical trial?
NCT05599438 is sponsored by Caroline Michaela Kistorp. The principal investigator is Caroline M Kistorp, Professor at Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet. The trial plans to enroll 900 participants.