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Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

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ClinicalTrials.gov Identifier: NCT00140998
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Turner Syndrome Hypogonadism Premature Ovarian Failure Drug: 17 beta estradiol Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery
Study Start Date : January 2001
Study Completion Date : June 2004





Primary Outcome Measures :
  1. Body Composition
  2. Rates of whole body protein kinetics
  3. Rates of whole body lipolysis

Secondary Outcome Measures :
  1. Changes in IGF-I concentrations
  2. Changes in Plasma Lipids


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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes 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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00140998     History of Changes
Other Study ID Numbers: 00-136
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: August 2017

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:
Syndrome
Hypogonadism
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Menopause, Premature
Disease
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
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
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Estradiol
Estrogens
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate