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NCT00740194 Clinical Trial

Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

Healthy Clinical Trial

Official title:
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00740194
Other study ID # 2007/279
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 21, 2008
Last updated August 29, 2011
Start date August 2008
Est. completion date August 2010

Study information
Verified date August 2011
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Aromatase inhibition versus estradiol during 1 week

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 2010
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aromatase inhibition
Letrozole
• Estradiol
Dermestril

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effects of sex steroids on adipocytes 1 week Yes
Secondary Effects of sex steroids on lipid metabolism 1 week Yes
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