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Growth Hormone Treatment of Women With Turner Syndrome
This study is currenly Recruiting patients.
Sponsored by:
University of Aarhus
Purpose
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.
Study Type: Intervention
| Condition | Intervention | Phase |
|
Turner Syndrome |
Array: Array Array: Array Array: Array | N/A |
Study Design:Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Official Title: Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.
Further Study Details:
Expected Total Enrollment:
Study Dates:August 2007 -
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
Eligibility
Ages Eligible for Study- Min: 20 Years Max: 40 Years
Gender: Female
Criteria
Inclusion Criteria:
Turner syndrome
Age 20-40
Exclusion Criteria:
Symptomatic heart disease
Anti hypertensive treatment
Untreated thyroid disease
Adipositas (BMI > 35)
Treatment with glucocorticoids
Pregnancy
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT00420654
More Information
Record Last Reviewed:December 2008
Last Updated:December 24, 2008
Record First Recieved:January 10, 2007
ClinicalTrials.gov Identifier:NCT00420654
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 02, 2010
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