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Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740194
First Posted: August 22, 2008
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
Aromatase inhibition versus estradiol during 1 week

Condition Intervention Phase
Healthy Drug: Aromatase inhibition Drug: Estradiol Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Effects of sex steroids on adipocytes [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Effects of sex steroids on lipid metabolism [ Time Frame: 1 week ]

Estimated Enrollment: 20
Study Start Date: August 2008
Study Completion Date: August 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aromatase inhibition
Drug: Aromatase inhibition
Letrozole
Active Comparator: 2
Estradiol
Drug: Estradiol
Dermestril

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740194


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Johannes Ruige, MD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00740194     History of Changes
Other Study ID Numbers: 2007/279
First Submitted: August 21, 2008
First Posted: August 22, 2008
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by University Hospital, Ghent:
Physiology
males

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female