Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy

Treatments

Drug: Estradiol

Drug: Aromatase inhibition

Study type

Interventional

Funder types

Other

Identifiers

2007/279

Details and patient eligibility

About

Aromatase inhibition versus estradiol during 1 week

Enrollment

20 estimated patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.