Initiating Transdermal Estradiol Therapy in Turner's Syndrome
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|ClinicalTrials.gov Identifier: NCT00870220|
Recruitment Status : Terminated (Poor accrual)
First Posted : March 27, 2009
Last Update Posted : March 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Turner's Syndrome||Drug: Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Initiating Transdermal Estradiol Therapy in Turner's Syndrome|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|