CompletedInterventionalPhase 3Updated Oct 22, 2010
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men | NCT00740194 | Trialant
CompletedInterventionalPhase 1Phase 2Updated Aug 30, 2011
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.
ClinicalTrials.gov ID
NCT00740194
Lead Sponsor
University Hospital, GhentOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1Phase 2
Enrollment
20Estimated
Last Update Posted
Aug 30, 2011Estimated
Start Date
Aug 2008
Primary Completion Date
Dec 2008Actual
Completion Date
Aug 2010Actual
Official Title
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.
Brief Summary
Aromatase inhibition versus estradiol during 1 week
Healthy
Aromatase inhibition
Estradiol
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
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.