Prospective, Longitudinal Study on FItness DOping in DenmarK

Infertility Clinical Trial

— FIDO-DK/RH  

Official title:

Prospective, Longitudinal Study of 800 Recreational Athletes With Current and Former Use of Performance and Image Enhancing Drugs (PIED), Focusing on Androgenic Anabolic Steroids (AAS) - Rigshospitalet

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599438
• Other study ID #: H-21035759
• Status: Recruiting
• Start date: June 14, 2022
• Est. completion date: June 1, 2040

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: Caroline M Kistorp, Professor
• Phone: 004535459642
• Email: caroline.michaela.kistorp[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Anabolic steroids (AAS) are synthetic derivates of the male sexhormone testosterone. The use of AAS is a growing phenomenon and have extended beyond the elite performance and body builder communities, involving a broader populace. The continued use causes a long-term impairment of testicular function, with symptoms of including impotence, depression, infertility and an increased risk of cardiovascular disease. AAS use is a clinical challenge as many psychological symptoms worsen in case of cessation of use. As AAS is often used by young individuals, the fulminant disease is rarely found by incidental screening. To assess long-term consequences, a large cohort is in need to be studied to accurately identify the risk of disease and when to initiate treatment. Furthermore, despite the use of AAS in women is present, the scientific community has thus far not taken notice, and the consequences are unknown, but are presumed to - beyond the changes in physical appearance - to include changes in fertility, risk of type 2 diabetes and cardiovascular disease. As AAS is acquired illicitly, the knowledge on the consequences of AAS use is sparse. No international or national consensus or recommendations exist as to the how to stop AAS use, screening of disease or therapeutic option in case of manifestations of symptoms or fulminant disease. The aim of the current study is to elucidate on the consequences of use of AAS in fitness circles in Denmark to assess the scope of therapeutic need.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: June 1, 2040
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Complication
• Fitness
• Illicit Drug Use
• Infertility
• Mental Health Issue

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Caroline Michaela Kistorp	Body Identity Clinic, Odense, Denmark, Centre for Preventative Doping Research at the German Sport University Cologne, Germany, Copenhagen University Hospital - Bispebjerg and Frederikssberg, Copenhagen, Denmark, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometry of the body composition of current and former users of AAS	Analysis on group-differences in lean and fat mass evaluated by Dual X-ray Absorptiometry	Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
Other	Extensive examination of the mental health of current and former users of AAS using questionnaires	Analysis on group-differences in response to questionnaires between current, former users of AAS and healthy controls (Questionnaires and further description found in protocol)	Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
Other	Extensive clinical characterization of current and former users of AAS	Analysis on group-differences in clinical characteristics between current, former users of AAS and healthy controls (Measures and further description found in protocol)	Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
Other	Extensive biochemical profile of current and former users of AAS	Analysis on group-differences in biochemical measures in blood and urine between current, former users of AAS and healthy controls (Measures and further description found in protocol)	Baseline comparison on entire cohort when initial completion is achieved (Date of primary completion)
Primary	Cardiovascular composite endpoint	Register-based composite of mortality, stroke, myocardial infarction, hospitalization due to heart failure and significant cardiovascular disease (See protocol)	15 years
Secondary	Fertility-related composite endpoint	Register-based composite of diagnoses related to fertility and testicular/ovarian function	15 years
Secondary	Metabolism-related composite endpoint	Register-based composite of diagnosis related to impaired metabolic function (See protocol)	15 years
Secondary	Mental health-related composite endpoint	Register-based composite of diagnosis related to psychiatric diagnosis (See protocol)	15 years
Secondary	Male fertility	Substudy analysis on difference in motile sperm count between groups (n=280 male participants; [current/former/controls] 60/60/80)	Baseline comparison when substudy is completed (expected 2023)
Secondary	Myocardial flow reserve	Substudy analysis on differences in myocardial flow reserve across groups (n=150 participants; male [current/former/controls]: 30/30/30; female [current/former/current]: 20/20/20)	Baseline comparison when substudy is completed (expected 2023)
Secondary	hCG stimulation test	Substudy analysis on difference in response to hCG stimulation test (n=60 male participants [former/controls]: 30/30)	Baseline comparison when substudy is completed (expected 2023)