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NCT05599438
Prospective, Longitudinal Study on FItness DOping in DenmarK
Conditions: Anabolic Steroid Overdose, Infertility, Cardiovascular Complication, Illicit Drug Use, Fitness, Mental Health Issue
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 900
Sponsor: Caroline Michaela Kistorp
Location: Denmark
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 diseaseCharacterization of illicit AAS use among men and womenCurrent male reproductive healthCurrent psychological well-being, aggressive tendencies, cognitive function and quality of lifeCurrent cardiovascular and metabolic statusThe participants will undergo:Semi-structured medical interviewPhysical examinationsQuestionnairesBlood and urine samplingDual X-ray AbsorptiometryWith 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 weeksInclusion 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.
Source: ClinicalTrials.gov (NCT05599438). StuddyBuddy aggregates publicly available trial information.