Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Aromatase inhibition; Drug: Estradiol

• Registration Number: NCT00740194
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Aromatase inhibition versus estradiol during 1 week

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Primary Completion: 2008-12
• Study Completion: 2010-08
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aromatase inhibition	Aromatase inhibition
2	Estradiol	Estradiol

Primary Outcome Measures

Name	Time	Method
Effects of sex steroids on adipocytes	1 week

Secondary Outcome Measures

Name	Time	Method
Effects of sex steroids on lipid metabolism	1 week

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium