Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

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. Identifier: NCT00740194
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
Aromatase inhibition versus estradiol during 1 week

Condition or disease Intervention/treatment Phase
Healthy Drug: Aromatase inhibition Drug: Estradiol Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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.
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Aromatase inhibition
Drug: Aromatase inhibition
Active Comparator: 2
Drug: Estradiol

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

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

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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.

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 identifier (NCT number): NCT00740194

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

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT00740194     History of Changes
Other Study ID Numbers: 2007/279
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by University Hospital, Ghent:

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