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Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

NCT ID: NCT00140998

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-06-30

Brief Summary

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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

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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.

Conditions

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Turner Syndrome Hypogonadism Premature Ovarian Failure

Keywords

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Turner syndrome Hypogonadism GH Estrogen Estrogen Patches IGF-I Body Composition Protein Metabolism Lipolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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17 beta estradiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Nemours Children's Clinic

OTHER

Sponsor Role lead

Principal Investigators

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Nelly Mauras, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Clinic

Locations

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Nemours Children's Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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00-136

Identifier Type: -

Identifier Source: org_study_id