Estrogen Treatment (Oral vs. Patches) in Turner Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Women's Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 10 - 16 |
| Updated: | 12/2/2017 |
| Start Date: | January 2001 |
| End Date: | June 2004 |
Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery
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.
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.
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.
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.
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.
We found this trial at
1
site
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
Click here to add this to my saved trials
