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Short-term Effects of Aromatase Inhibition in Obese Men

NCT ID: NCT00138710

Last Updated: 2010-10-22

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

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-01-31

Brief Summary

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In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or placebo for six months in order to examine the effects on the hormonal balance, and on weight loss. The study will also address the side effects and psychological effects of letrozole as compared to placebo.

Detailed Description

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The aim of the study is to establish the short-term efficacy and safety of aromatase inhibition in restoring and maintaining eugonadism in hypogonadotrophic hypogonadal men. Secondary aim is to detect the short-term somatic and psychological effects.

Study design: Double blind randomized placebo-controlled trial.

Treatment: 26 weeks of either letrozole or placebo. All patients will start on 1 tablet per week, dose adjustments will be performed if serum testosterone or estradiol are outside the target range. All men will be prescribed a mildly hypocaloric diet.

Endpoints: BMI, body weight, waist circumference, body composition, exercise capacity, serum levels of several hormone markers, glucose tolerance, psychological characteristics.

All patients will be measured 6 times during the study.

Conditions

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Hypogonadotrophic Hypogonadism Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Letrozole (Femara)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI between 35 and 50
* Male sex
* Ages between 20 and 50
* Serum total testosterone under 10 nmol/l
* Serum luteinizing hormone (LH) under 9 mU/l
* Serum estradiol over 40 pmol/l

Exclusion Criteria

* Comorbidity
* Serum prostate-specific antigen (PSA) over 4.0 U/l
* Discontinuation of smoking less than six months ago
* Medication known to affect hormonal parameters
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Hans de Boer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital, Arnhem, the Netherlands

Locations

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Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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LTC-323-150405

Identifier Type: -

Identifier Source: org_study_id