Initiating Transdermal Estradiol Therapy in Turner's Syndrome
This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of estradiol administered by recently available transdermal patches for the initiation of puberty in Turner syndrome girls 11.5-13.0 years old in conjunction with growth hormone (GH) therapy.
The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment, low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating feminization, height velocity, and bone mineral density without compromising growth potential than very low dose transdermal estradiol (VLTE2), which will in turn be superior to GH alone in effects on feminization, height velocity, and bone mineral density.
|Turner's Syndrome||Drug: Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Initiating Transdermal Estradiol Therapy in Turner's Syndrome|
- The net change of height velocity between Group 2 and Group 3 and the net change in predicted height between Group 2 and Group 3. [ Time Frame: 12 months ]
- Plasma E2 level to document the dose-response effect of the applied prescription and uterine dimensions to quantitate the estrogenic effect on growth and development of the uterus. [ Time Frame: 12 months ]
|Study Start Date:||April 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: GH alone, Low dose E2 patch, Very Low-dose E2 patch
Group 1: Growth hormone alone, no E2. Group 2: Growth Hormone plus Estradiol patch dose A(14 mcg/d x 10 d) x 6 months then Estradiol patch dose B(25 mcg/d x 10 d) x 6 months.
Group 3: Growth Hormone plus Estradiol patch dose B(25 mcg/d x 10 d) x 6 months then Estradiol patch dose C(25 mcg/d x 3 w) x 6 months.
Drug: Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch
GH will be maintained at 0.05mg/kg/d, adjusted every 3 months. Estradiol 14mcg patch will be applied for 10 days/month for the first 6 months in Group 2. Estradiol 25mcg patch will be applied for 10 days/month for the second 6 months in Group 2, and for the first 6 months in Group 3. Estradiol 25mcg patch will be applied for 3 weeks per month for the second 6 months in Group 3.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00870220
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|John Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Robert L. Rosenfield, MD||University of Chicago|