Somatropin Treatment to Final Height in Turner Syndrome

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Hormones; Medroxyprogesterone; Medroxyprogesterone Acetate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• girl with Turner syndrome

• prepubertal, Tanner stage I breast

• height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population

• at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity

• if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests

Exclusion Criteria:

• prior treatment with growth hormone

• presence of a Y component in karyotype with gonads in situ

• diabetes mellitus