Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

NCT00740194 | Completed Phase 1

• 1 other identifier: 2007/279
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Aromatase inhibition versus estradiol during 1 week

Conditions

Healthy

Keywords

Physiology; males

Outcome Measures

Primary Outcomes (1)

• Effects of sex steroids on adipocytes

  1 week

Secondary Outcomes (1)

• Effects of sex steroids on lipid metabolism

  1 week

Study Arms (2)

1

EXPERIMENTAL

Aromatase inhibition

Drug: Aromatase inhibition

2

ACTIVE COMPARATOR

Estradiol

Drug: Estradiol

Interventions

Aromatase inhibition DRUG

Letrozole

1

Estradiol DRUG

Dermestril

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent obtained.
• Male subjects
• Age 18 - 40
• weight \< 120 kg

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Website of the University Hospital Ghent

MeSH Terms

Interventions

Aromatase Inhibitors; Estradiol

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones

Study Officials

• Johannes Ruige, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2010
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

BE (1)