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NCT00837616 · ClinicalTrials.gov registry record · Phase 4
Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism
A Phase 4 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
NCT00837616 is a Phase 4 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 41 participants.
The verdict
NCT00837616, a Phase 4 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
Study Summary
Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pediatric endocrinologist often faces the dilemma of how to best feminize girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to disorders of the brain or the ovaries. We propose a series of studies to address which type, dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the clinical research center for blood draws after 2 wks of taking the estrogen. With this study, we hope to learn how the body responds to estrogen differently, depending on the form estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner Syndrome. We will be comparing these patients estrogen levels to girls that menstruate normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be recruited; these patients will take estrogen for 1 year, either by mouth or via a patch. Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray absorptiometry (DXA) study (like an X ray) to assess body composition and bone mineralization. We will adjust doses based on the estrogen levels we find. With this study we hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and how different forms of estrogen affect blood cholesterol and other hormones. This study will allow us to un
Interventions
- DRUG 17 B estradiol orally
- DRUG 17 B estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00837616
The ClinicalTrials.gov registry entry for NCT00837616 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 17 B estradiol orally is the first listed.
NCT00837616 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00837616 about?
NCT00837616 is a clinical study titled "Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism". Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pediatric endocrinologist often faces the dilemma of how to best feminize girls with hypogonadism (lac...
What is the current status of trial NCT00837616?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2009-01. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00837616?
The interventions under investigation include: 17 B estradiol orally (DRUG), 17 B estradiol (DRUG).
Who is sponsoring clinical trial NCT00837616?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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