At a glance
ClinicalIndex Comparison Record- ✓Confirmed Turner syndrome diagnosis
- ✓Prepubertal status (Tanner stage I breast development)
- ✓Growth failure: height velocity <6 cm/year AND height ≤10th percentile for age/sex
- ✓At least 6 months (preferably 12 months) of documented pre-study height measurements to establish baseline growth velocity
- ✕Prior treatment with growth hormone
- ✕Presence of Y chromosome material with gonads in situ (increased malignancy risk)
- ✕History of diabetes mellitus
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Humatrope Treatment to Final Height in Turner's Syndrome
In Brief
A Phase 3 clinical trial evaluating Somatropin, Ethinyl estradiol, and 1 other intervention for Turner Syndrome. Completed, enrolled 154 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).
escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met.
10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.