NCT00138710

CompletedPhase 3

Short-term Effects of Aromatase Inhibition in Obese Men

Rijnstate Hospital Source

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Other study identifiers

Sponsor study identifier

LTC-323-150405

Study Type

interventional

Estimated enrollment

50

Locations

1 country

Sites

1

Timeline

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2010

Actual (reported)

Study Completion

January 2010

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 50 participants
Study completion date: January 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 29, 2005
Actual (reported)
First Posted
August 30, 2005
Actual (reported)
Primary Completion
January 2010
Actual (reported)
Study Completion
January 2010
Actual (reported)

Last Updated: October 22, 2010
Status Verified: October 2010
Last Update Submitted: October 21, 2010

Conditions

Hypogonadotrophic Hypogonadism Obesity

Keywords

obesityHypogonadotrophic hypogonadismaromatase inhibition

Outcome Measures

Primary Outcomes (9)

Body weight
Body mass index (BMI)
Waist circumference
Body composition
Exercise capacity
Serum levels of hormones
Glucose tolerance
Reported side effects
Psychological characteristics (Symptom Checklist, intelligence quotient [IQ] NPV)

Secondary Outcomes (4)

Lipid profile
Blood counts
Bone markers
Liver enzymes

Interventions

Letrozole (Femara)Drug

Eligibility Criteria

Age20 Years - 50 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

BMI between 35 and 50
Male sex

Sponsors & Collaborators

Rijnstate Hospital
Otherlead

Study Sites (1)

Rijnstate Hospital

Arnhem, 6815 AM, Netherlands

MeSH Terms

Conditions

HypogonadismObesity

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitriles

Study Officials

Hans de Boer, MD PhD
Rijnstate Hospital, Arnhem, the Netherlands
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2010

Actual (reported)

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Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

Phase 3Completed

NCT00382070

Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

Phase 3Unknown

NCT00553410

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer

Phase 3Completed

NCT01577017

The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS)

Phase 3Completed

NCT02097680

Influence of Aromatase Inhibition on Hepatic- and Cardiac Function in Severe Obese Men

Phase 4Completed

NCT00673335

Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation

Phase 3Completed

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Organic Chemicals

Triazoles

Azoles

Heterocyclic Compounds, 1-Ring

Heterocyclic Compounds

Study Completion

January 2010

Actual (reported)

Last Updated

October 22, 2010

Record last verified: 2010-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00138710
Data provider: ClinicalTrials.gov
Source updated: 2010-10-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:15 UTC

Locations

NL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (9)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations