Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: August 21, 2008
Last updated: August 29, 2011
Last verified: August 2011

Aromatase inhibition versus estradiol during 1 week

Condition Intervention Phase
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
Active Comparator: 2
Drug: Estradiol


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Please refer to this study by its identifier: NCT00740194

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

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent 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:

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female processed this record on April 23, 2014