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Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00140998
First received: August 30, 2005
Last updated: August 12, 2010
Last verified: August 2010
History of Changes
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nemours Children's Clinic:

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

Estimated Enrollment: 16
Study Start Date: January 2001
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140998

Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Eli Lilly and Company
Investigators
Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00140998     History of Changes
Other Study ID Numbers: 00-136
Study First Received: August 30, 2005
Last Updated: August 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:
Turner syndrome
Hypogonadism
GH
Estrogen
Estrogen Patches
 IGF-I
Body Composition
Protein Metabolism
Lipolysis

Additional relevant MeSH terms:
Hypogonadism
Menopause, Premature
Primary Ovarian Insufficiency
Turner Syndrome
Gonadal Dysgenesis
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013