Initiating Transdermal Estradiol Therapy in Turner's Syndrome
Status:
Terminated
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Chicago
Collaborators:
Johns Hopkins University Massachusetts General Hospital Novo Nordisk A/S Thomas Jefferson University University of Michigan University of Oklahoma University of South Florida