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| Sponsors and Collaborators: |
Nemours Children's Clinic Eli Lilly and Company |
|---|---|
| Information provided by: | Nemours Children's Clinic |
| ClinicalTrials.gov Identifier: | NCT00140998 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study |
| Official Title: | Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery |
| Estimated Enrollment: | 16 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | June 2004 |
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 |
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| United States, Florida | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Principal Investigator: | Nelly Mauras, MD | Nemours Children's Clinic |
More Information
| Study ID Numbers: | 00-136 |
| Study First Received: | August 30, 2005 |
| Last Updated: | August 31, 2005 |
| ClinicalTrials.gov Identifier: | NCT00140998 |
| Health Authority: | United States: Institutional Review Board |
|
Turner syndrome Hypogonadism GH Estrogen Estrogen Patches |
IGF-I Body Composition Protein Metabolism Lipolysis |
|
Chromosomal abnormalities Genital dwarfism Gonadal Disorders Estradiol valerate Ovarian Diseases Estradiol 17 beta-cypionate Sex Differentiation Disorders Genital Diseases, Female Gonadal dysgenesis Urogenital Abnormalities Estradiol 3-benzoate Congenital Abnormalities Polyestradiol phosphate |
Benzoates Chromosome Disorders Endocrine System Diseases Ovarian Failure, Premature Monosomy X Estradiol Turner Syndrome Hypogonadism Genetic Diseases, Inborn Turner syndrome Ovarian dwarfism Endocrinopathy Gonadal Dysgenesis |
|
Estrogens Disease Contraceptive Agents Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents |
Hormones Pharmacologic Actions Adnexal Diseases Pathologic Processes Syndrome Therapeutic Uses Sex Chromosome Disorders |
