Anabolic Steroid OverdoseFIDO-DK/RHNCT05599438
Prospective, Longitudinal Study on FItness DOping in DenmarK
An observational study of Anabolic Steroid Overdose and Infertility, run by Caroline Michaela Kistorp at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anabolic Steroid Overdose, Infertility, Cardiovascular Complication
- How many people
- 900 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Jun 2022to 1 Jun 2040
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with current or former use of anabolic steroids of both male and female sex. The study also includes a control group (n=100 [male/female] - 80/20)
Who may be able to join
- 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
- Male (n=80) or female (n=20) recreational athletes (≥18 years of age) with NO current or former illicit use of AAS.
Who cannot join
- Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program.
- Known pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Caroline Kistorp, Professor, 004535459642, caroline.michaela.kistorp@regionh.dk
Yeliz Bulut, MD, 004535458079, yeliz.bulut@regionh.dk
About this study
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
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
Read more
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.
Read the detailed 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.
- Conditions
- Anabolic Steroid Overdose, Infertility, Cardiovascular Complication, Illicit Drug Use, Fitness, Mental Health Issue
- Being tested
- No intervention
- Keywords
- Cardiovascular Disease, Metabolic syndrome, Infertility, Mortality
- Medical subject headings
- Infertility, Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Current users anabolic steroids | Current users of anabolic steroids with a use of more than 4 weeks Receives: Other: No intervention | |
| Former users of anabolic steroids | Former users of anabolic steroids with a use of more than 4 weeks Receives: Other: No intervention | |
| Healthy controls | 100 participants with no former use of anabolic steroids
* 80 Male
* 20 Female Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular composite endpoint
Register-based composite of mortality, stroke, myocardial infarction, hospitalization due to heart failure and significant cardiovascular disease (See protocol)
Measured: 15 years
Secondary outcomes (6)
Fertility-related composite endpoint
Register-based composite of diagnoses related to fertility and testicular/ovarian function
Measured: 15 years
Metabolism-related composite endpoint
Register-based composite of diagnosis related to impaired metabolic function (See protocol)
Measured: 15 years
Mental health-related composite endpoint
Register-based composite of diagnosis related to psychiatric diagnosis (See protocol)
Measured: 15 years
Male fertility
Substudy analysis on difference in motile sperm count between groups (n=280 male participants; [current/former/controls] 60/60/80)
Measured: Baseline comparison when substudy is completed (expected 2023)
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)
Measured: Baseline comparison when substudy is completed (expected 2023)
hCG stimulation test
Substudy analysis on difference in response to hCG stimulation test (n=60 male participants [former/controls]: 30/30)
Measured: Baseline comparison when substudy is completed (expected 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start14 Jun 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anabolic Steroid OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Caroline Michaela Kistorp
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, University Hospital Bispebjerg and Frederiksberg, German Sport University, Cologne, Body Identity Clinic, Odense, Denmark
- Responsible party
- Sponsor-investigator, Caroline Michaela Kistorp, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Caroline M Kistorp, Professor, Principal investigator, Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599438
- Sponsor's protocol ID
- H-21035759
- Acronym
- FIDO-DK/RH
- Status last verified
- Feb 2024
- First submitted
- 19 Oct 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to national judicial restrictions individual participant data cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05599438
- Acronym / sponsor ID
- FIDO-DK/RH / H-21035759
- Conditions
- Anabolic Steroid Overdose, Infertility, Cardiovascular Complication, Illicit Drug Use, Fitness, Mental Health Issue
- Keywords
- Cardiovascular Disease, Metabolic syndrome, Infertility, Mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Caroline Michaela KistorpUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, University Hospital Bispebjerg and Frederiksberg, German Sport University, Cologne, Body Identity Clinic, Odense, Denmark
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2040 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current users anabolic steroids | – | Other: No interventionCurrent users of anabolic steroids with a use of more than 4 weeks |
| Former users of anabolic steroids | – | Other: No interventionFormer users of anabolic steroids with a use of more than 4 weeks |
| Healthy controls | – | Other: No intervention100 participants with no former use of anabolic steroids * 80 Male * 20 Female |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with current or former use of anabolic steroids of both male and female sex. The study also includes a control group (n=100 [male/female] - 80/20)
Key inclusion criteria (2 listed)
- 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
- Male (n=80) or female (n=20) recreational athletes (≥18 years of age) with NO current or former illicit use of AAS.
Key exclusion criteria (2 listed)
- Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program.
- Known pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Current users anabolic steroids, Former users of anabolic steroids, Healthy controls |
Primary outcome
Cardiovascular composite endpoint
Time frame: 15 years
Register-based composite of mortality, stroke, myocardial infarction, hospitalization due to heart failure and significant cardiovascular disease (See protocol)
6 secondary outcomes
Fertility-related composite endpoint
Time frame: 15 years
Metabolism-related composite endpoint
Time frame: 15 years
Mental health-related composite endpoint
Time frame: 15 years
Male fertility
Time frame: Baseline comparison when substudy is completed (expected 2023)
Myocardial flow reserve
Time frame: Baseline comparison when substudy is completed (expected 2023)
hCG stimulation test
Time frame: Baseline comparison when substudy is completed (expected 2023)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No. Due to national judicial restrictions individual participant data cannot be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline M Kistorp, Professor principal investigator
Centre for Cancer and Organ Disease, Department for Medical Endocrinology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anabolic Steroid Overdose and Infertility, run by Caroline Michaela Kistorp at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline M Kistorp, Professor (004535459642, caroline.michaela.kistorp@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular composite endpoint (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.