Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

NCT ID: NCT02240966

Last Updated: 2016-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Recent studies have shown that metabolic syndrome is common among testicular cancer. Patients with low levels of testosterone appear to be at higher risk of metabolic syndrome.

A substantial number of testicular cancer survivors might be in a state of "compensated hypogonadism" with testosterone levels low in the normal range due to an increased LH-drive from the pituitary gland.

Whether this specific groups of testicular cancer survivors are at increased risk of cardio-vascular disease and might benefit from testosterone substitution is yet to be clarified.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome Hypogonadism Cardio-vascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Earlier treatment of testicular germ cell cancer
* No sign of relapse \> 1 year since latest treatment
* Testosterone \< 12 nmol/L and luteinizing hormone \> 8 IE/L OR
* Testosterone \> 12 nmol/L and LH \> 8 IE/L OR
* Testosterone and LH within their normal ranges

Exclusion Criteria

* Testosterone substitution
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mikkel Bandak

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gedske Daugaard, DMSc

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Bandak M, Jorgensen N, Juul A, Lauritsen J, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Leydig cell dysfunction, systemic inflammation and metabolic syndrome in long-term testicular cancer survivors. Eur J Cancer. 2017 Oct;84:9-17. doi: 10.1016/j.ejca.2017.07.006. Epub 2017 Jul 31.

Reference Type DERIVED
PMID: 28772110 (View on PubMed)

Bandak M, Jorgensen N, Juul A, Lauritsen J, Kier MGG, Mortensen MS, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Reproductive hormones and metabolic syndrome in 24 testicular cancer survivors and their biological brothers. Andrology. 2017 Jul;5(4):718-724. doi: 10.1111/andr.12355. Epub 2017 Jun 9.

Reference Type DERIVED
PMID: 28598554 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-3-2013-1 75

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.