Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT00740194
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Aromatase inhibition	Drug: Aromatase inhibition; Letrozole
Active Comparator: 2 Estradiol	Drug: Estradiol; Dermestril

Outcome Measures

Primary Outcome Measures

1. Effects of sex steroids on adipocytes [1 week]

Secondary Outcome Measures

1. Effects of sex steroids on lipid metabolism [1 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the University Hospital Ghent

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT00740194
• Other Study ID Numbers: 2007/279
• First Posted: Aug 22, 2008
• Last Update Posted: Aug 30, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by University Hospital, Ghent: Physiology; males
• Additional relevant MeSH terms: Estradiol

Study Results

No Results Posted as of Aug 30, 2011