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Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

Primary Purpose

Turner Syndrome, Hypogonadism, Premature Ovarian Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
17 beta estradiol
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Turner Syndrome focused on measuring Turner syndrome, Hypogonadism, GH, Estrogen, Estrogen Patches, IGF-I, Body Composition, Protein Metabolism, Lipolysis

Eligibility Criteria

10 Years - 16 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:Girls with Turner syndrome 10-16 years old who are receiving growth hormone treatment. - Exclusion Criteria:Systemic disease or concomitant treatment wtih Oxandrolone. Significant obesity or chronic steroid use. -

Sites / Locations

  • Nemours Children's Clinic

Outcomes

Primary Outcome Measures

Body Composition
Rates of whole body protein kinetics
Rates of whole body lipolysis

Secondary Outcome Measures

Changes in IGF-I concentrations
Changes in Plasma Lipids

Full Information

First Posted
August 30, 2005
Last Updated
November 28, 2017
Sponsor
Nemours Children's Clinic
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00140998
Brief Title
Estrogen Treatment (Oral vs. Patches) in Turner Syndrome
Official Title
Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nemours Children's Clinic
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner Syndrome, Hypogonadism, Premature Ovarian Failure
Keywords
Turner syndrome, Hypogonadism, GH, Estrogen, Estrogen Patches, IGF-I, Body Composition, Protein Metabolism, Lipolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
17 beta estradiol
Primary Outcome Measure Information:
Title
Body Composition
Title
Rates of whole body protein kinetics
Title
Rates of whole body lipolysis
Secondary Outcome Measure Information:
Title
Changes in IGF-I concentrations
Title
Changes in Plasma Lipids

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Girls with Turner syndrome 10-16 years old who are receiving growth hormone treatment. - Exclusion Criteria:Systemic disease or concomitant treatment wtih Oxandrolone. Significant obesity or chronic steroid use. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly Mauras, MD
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States

12. IPD Sharing Statement

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Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

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