Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-08-31

Brief Summary

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Aromatase inhibition versus estradiol during 1 week

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Aromatase inhibition

Group Type EXPERIMENTAL

Aromatase inhibition

Intervention Type DRUG

Letrozole

2

Estradiol

Group Type ACTIVE_COMPARATOR

Estradiol

Intervention Type DRUG

Dermestril

Interventions

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Aromatase inhibition

Letrozole

Intervention Type DRUG

Estradiol

Dermestril

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes