Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00406926 | The Effect of Growth Hormone in Very Young Girls With Turner Syndrome | PHASE3 | COMPLETED | 100 | — | — | Aug 1, 1999 | Aug 1, 2003 | Dec 4, 2006 | 10 | United States |
| NCT00191113 | Somatropin Treatment to Final Height in Turner Syndrome | PHASE3 | COMPLETED | 154 | — | — | Feb 1, 1989 | Dec 1, 2007 | Jan 27, 2010 | 14 | Canada |
Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.
SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS \[NCHS\] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS \[Lyon\] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS \[NCHS\] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.
| Arm | Type | Description |
|---|---|---|
| Control | NO_INTERVENTION | Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| Humatrope | EXPERIMENTAL | Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). |
| Name | Type | Description |
|---|---|---|
| Somatropin | DRUG | - |
| Ethinyl estradiol | DRUG | 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. |
| Medroxyprogesterone acetate | DRUG | 10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met. |
Inclusion Criteria: * Karyotype-proven Turner syndrome that included a documented abnormality of the short arm of an X chromosome. * At least 9 months of age and not greater than 4 years of age. * Normal values for age for hemoglobin, thyroid stimulating hormone (TSH) and urinalysis (office dipstic...