Initiating Transdermal Estradiol Therapy in Turner's Syndrome

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• On estrogen therapy, breast stage 2 or greater, not on GH for at least 6 months.