Initiating Transdermal Estradiol Therapy in Turner's Syndrome
Stopped early · Phase 1
Conditions studied: Turner's Syndrome
In brief
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.
Key facts
- Study ID
- NCT00870220
- Run by
- University of Chicago
- People needed
- 1
- Starts
- 2009-04-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2014-03-11
Who can join
Age: 12 and older, up to 13. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 60 subjects will be recruited from participating Pediatric Endocrinology Clinics in the United States.
- Subjects will be 11.5-13.0 years of age and must have completed at least 6 months of GH therapy prior to the study.
- Subjects may not have had any estrogen prior to the study. All subjects must be breast stage 1 and euthyroid prior to the study
- Those on thyroid medication will continue the appropriate thyroid replacement therapy during the study.
You may not qualify if…
- On estrogen therapy, breast stage 2 or greater, not on GH for at least 6 months.
Where it is running
- University of Chicago — Chicago, Illinois, United States
- John Hopkins University — Baltimore, Maryland, United States
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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