Turner's Syndrome Clinical Trial
Official title:
The Relative Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate, GH Binding Protein, IGF-I, and Cognitive Function in Growth Hormone-Treated Girls With Turner Syndrome
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes.
Patients with Turner syndrome are typically short, have abnormal physical features, and lack
the physical changes normally associated with puberty. In addition, some patients with Turner
syndrome have low bone density (osteoporosis) and differences in learning abilities.
This study will research the effects of steroid hormones on patients with Turner syndrome. It
will look closely at how taking steroid hormones effects the patient's rate of growth as well
as the patient's ability to learn. In addition the study will investigate how different
hormones (androgen and estrogen) work when given together as a combination.
All patients asked to participate in this study will receive growth hormone injections.
However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in
the form of a pill. The other half of the patients will receive a placebo or "sugar pill".
This will allow the researchers to determine if the combination of the hormones produces
different results than growth hormone alone.
The study will last approximately 2 years. After 2 years of research the patients may qualify
for an additional 2 years of treatment. Patients may benefit directly from this research with
increased growth and improved ability to learn.
Turner syndrome is associated with short stature, multiple physical stigmata, and absent pubertal development. We propose to: (1) examine the effects of sex steroids (androgen) on multiple variables (growth rate, GH binding protein, IGF-I, and cognitive function), in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination on the above variables. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00006334 -
Turner Syndrome: Genotype and Phenotype
|
N/A | |
| Not yet recruiting |
NCT02871986 -
Pubertal Induction in Individuals With Hypogonadism
|
N/A | |
| Completed |
NCT01306357 -
Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
|
||
| Completed |
NCT00001221 -
Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome
|
Phase 2 | |
| Completed |
NCT00250250 -
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
|
Phase 3 | |
| Completed |
NCT00004275 -
Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
|
Phase 2 | |
| Completed |
NCT00001253 -
The Effects of Estrogen on Cognition in Girls With Turner Syndrome
|
Phase 2 | |
| Completed |
NCT00013546 -
Hormone Replacement Therapy to Treat Turner Syndrome
|
Phase 2 | |
| Terminated |
NCT02018172 -
Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device
|
N/A | |
| Completed |
NCT01066052 -
Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years
|
Phase 4 | |
| Completed |
NCT01813630 -
A Clinical Study to Assess the Efficacy and Safety of DA-3002
|
Phase 3 | |
| Completed |
NCT00004274 -
Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome
|
N/A | |
| Terminated |
NCT00870220 -
Initiating Transdermal Estradiol Therapy in Turner's Syndrome
|
Phase 1 |