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Register:	ClinicalTrials.gov
Last refreshed on:	8 August 2016
Main ID:	NCT02240966
Date of registration:	08/09/2014
Prospective Registration:	No
Primary sponsor:	Rigshospitalet, Denmark
Public title:	Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
Scientific title:	Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
Date of first enrolment:	August 2014
Target sample size:	200
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02240966
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Cross-Sectional
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	Gedske Daugaard, DMSc
Address:
Telephone:
Email:
Affiliation:	Rigshospitalet, Denmark

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Hypogonadism

Cardio-vascular Disease

Metabolic Syndrome

Intervention(s)

Primary Outcome(s)

Prevalence of Metabolic Syndrome in the three groups of testicular cancer survivors according to International Diabetes Federation Guidelines and US National Cholesterol Education Program Adult Treatment Panel III criteria [Time Frame: Up to 12 months]

Secondary Outcome(s)

Anxiety and depression [Time Frame: Up to 12 months]

Fatigue [Time Frame: Up to 12 months]

Lean body mass (Kilogram) [Time Frame: Up to 12 months]

Ultrasonic appearance and size of the remaining testicle [Time Frame: Up to 12 months]

plasma-insulin [Time Frame: Up to 12 months]

Bone Mineral Density (Gram/cm2) [Time Frame: Up to 12 months]

Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide [Time Frame: Up to 12 months]

Adiponectin and leptin [Time Frame: Up to 12 months]

Fasting Blood Glucose [Time Frame: Up to 12 months]

Renal function (Glomerular Filtration Rate ml/min) [Time Frame: Up to 12 months]

Quality of life [Time Frame: Up to 12 months]

Secondary ID(s)

H-3-2013-1 75

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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