NCT00138710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 22, 2010

Status Verified

October 1, 2010

Enrollment Period

4.4 years

First QC Date

August 29, 2005

Last Update Submit

October 21, 2010

Conditions

Hypogonadotrophic HypogonadismObesity

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, 6815 AM, Netherlands

Location

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)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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 1, 2005

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 22, 2010

Record last verified: 2010-10

Locations

NL(1)