Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00740194
First received: August 21, 2008
Last updated: August 29, 2011
Last verified: August 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects of sex steroids on lipid metabolism [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00740194     History of Changes
Other Study ID Numbers: 2007/279
Study First Received: August 21, 2008
Last Updated: August 29, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Physiology
males

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

ClinicalTrials.gov processed this record on September 14, 2014