Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT00740194
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained.
* Male subjects
* Age 18 - 40
* weight \< 120 kg
Exclusion Criteria:
* Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
* Treatment with insulin, corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
* Impaired renal function defined as serum-creatine \> 1.5 mg/dL
* Impaired liver function, defined as ALAT \> 2.5 times upper limit of normal
* Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator
* Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial
* Palpable prostate nodule or induration, PSA \> 3 ng/mL, prostatism, untreated sleep apnee syndrome, erythrocytosis (hematocrit \> 50%) or hyperviscosity.
* Known or suspected abuse of alcohol or narcotics
* Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00740194
Study Brief:
Protocol Section:
NCT00740194