Status:
COMPLETED
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men
Lead Sponsor:
University Hospital, Ghent
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
Aromatase inhibition versus estradiol during 1 week
Eligibility Criteria
Inclusion
- Informed consent obtained.
- Male subjects
- Age 18 - 40
- weight \< 120 kg
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00740194
Start Date
August 1 2008
End Date
August 1 2010
Last Update
August 30 2011
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000