Skip to main content
OpenTrials
Completed

NCT Number: NCT00740194

Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

Aromatase inhibition versus estradiol during 1 week

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aromatase inhibition

Drug

Letrozole

Estradiol

Drug

Dermestril

Primary outcomes

  1. Effects of sex steroids on adipocytes

    Time frame: 1 week

Secondary outcomes

  1. Effects of sex steroids on lipid metabolism

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Aug 22, 2008
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.