The study attempts to evaluate if the way of administering estrogen, the principal female hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome. These are girls who are very short and whose ovaries do not work. We will examine changes bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH therapy.

Condition	Intervention	Phase
Turner syndrome, Hypogonadism Premature Ovarian Failure	Drug: 17 beta estradiol	Phase III

Further Study Details: 

Primary Outcomes: Body Composition; Rates of whole body protein kinetics; Rates of whole body lipolysis
Secondary Outcomes: Changes in IGF-I concentrations; Changes in Plasma Lipids
Expected Total Enrollment:  16

Girls with Turner Syndrome, between the ages of 10-16 years, were chosen as the study population. The study requires 3 overnight admissions to an in-patient Clinical Research Center(CRC). A baseline study is performed using stable isotope tracers of leucine, glycerol and glucose and serial blood sampling to measure protein and fat metabolism. Indirect calorimetry is used to measure substrate oxidation rates and total energy expenditure. DEXA scan is used to measure bone mineral density and body composition. Once the baseline study is complete subjects are randomly assigned to receive either estrogen orally or through a patch placed onto the skin in increasing doses changed every 2 weeks. After 6 weeks of estrogen treatment a second metabolic study, identical to the first, is performed, followed by a wash out period of 4 weeks. Subsequently, the subjects are switched to the alternate form of estrogen. At the end of 6 weeks a third and final metabolic study is repeated. All subjects continue to be on growth hormone throughout the study procedures.

Ages Eligible for Study:  10 Years   -   16 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:Girls with Turner syndrome 10-16 years old who are receiving growth hormone treatment.

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Exclusion Criteria:Systemic disease or concomitant treatment wtih Oxandrolone. Significant obesity or chronic steroid use.

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Florida
      Nemours Children''''s Clinic, Jacksonville,  Florida,  32207,  United States

Study chairs or principal investigators

Nelly Mauras, MD,  Principal Investigator,  Nemours Children''''s Clinic   

Study ID Numbers:  00-136
Last Updated:  September 1, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00140998
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13