Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

August 29, 2011 updated by: University Hospital, Ghent

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

Aromatase inhibition versus estradiol during 1 week

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Aromatase inhibition
Drug: Aromatase inhibition
Letrozole
ACTIVE_COMPARATOR: 2
Estradiol
Drug: Estradiol
Dermestril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of sex steroids on adipocytes
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects of sex steroids on lipid metabolism
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Johannes Ruige, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (ESTIMATE)

August 22, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/279

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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