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Completed

NCT Number: NCT00140998

Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

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.

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Key information

Conditions

Turner Syndrome Adnexal Diseases Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Hypogonadism Male Urogenital Diseases Ovarian Diseases Premature Ovarian Failure Primary Ovarian Insufficiency Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

10 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

17 beta estradiol

Drug

Primary outcomes

  1. Body Composition

  2. Rates of whole body protein kinetics

  3. Rates of whole body lipolysis

Secondary outcomes

  1. Changes in IGF-I concentrations

  2. Changes in Plasma Lipids

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery

Important dates

Study start
2001
Study completion
2004
First posted
Sep 1, 2005
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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