Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
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 understand better how to best replace young woman with Turner Syndrome with
estrogen.