Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

Phase 3

Completed

• Conditions: Hypogonadism; Premature Ovarian Failure; Turner Syndrome

• Registration Number: NCT00140998
• Lead Sponsor: Nemours Children's Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2004-06
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Rates of whole body protein kinetics
Rates of whole body lipolysis
Body Composition

Secondary Outcome Measures

Name	Time	Method
Changes in Plasma Lipids
Changes in IGF-I concentrations

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States