Clinical Trials Directory

Trials / Completed

CompletedNCT00420654

Growth Hormone Treatment of Women With Turner Syndrome

Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Britta E. Hjerrild · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Not accepted

Summary

Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.

Detailed description

This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET). Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment

Conditions

Interventions

TypeNameDescription
DRUGGrowth Hormone1.25 mg, 6 months
DRUGPlaceboEquivalent to 1.25 mg, 6 months
OTHERHealthy controlsHealthy controls

Timeline

Start date
2007-08-01
Primary completion
2011-09-01
Completion
2011-09-01
First posted
2007-01-11
Last updated
2011-11-08

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT00420654. Inclusion in this directory is not an endorsement.