Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

Aromatase inhibition versus estradiol during 1 week

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

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.