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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00138710
Other study ID # LTC-323-150405
Secondary ID
Status Completed
Phase Phase 3
First received August 29, 2005
Last updated October 21, 2010
Start date August 2005
Est. completion date January 2010

Study information

Verified date October 2010
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Letrozole (Femara)


Locations

Country Name City State
Netherlands Rijnstate Hospital Arnhem

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight
Primary Body mass index (BMI)
Primary Waist circumference
Primary Body composition
Primary Exercise capacity
Primary Serum levels of hormones
Primary Glucose tolerance
Primary Reported side effects
Primary Psychological characteristics (Symptom Checklist, intelligence quotient [IQ] NPV)
Secondary Lipid profile
Secondary Blood counts
Secondary Bone markers
Secondary Liver enzymes
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