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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01090778 | Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) | PHASE2 | COMPLETED | 8 | — | — | Oct 1, 2010 | Dec 1, 2011 | Jan 9, 2014 | 2 | Denmark |
Pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as a bolus in the adult patients with growth hormone deficiency during interval exercise or in supine rest.
| Arm | Type | Description |
|---|---|---|
| Norditropin SimpleXx sc bolus injection | OTHER | Single sc bolus injection of 3 mg growth hormone without interval exercise |
| Norditropin SimpleXx single sc injection | OTHER | Single sc bolus injection of 3 mg growth hormone with interval exercise |
| Norditropin SimpleXx contin. sc infusion | OTHER | Continuous sc infusion of 3 mg growth hormone without interval exercise |
| Norditropin SimpleXx cont. sc infusion | OTHER | Continuous sc infusion of 3 mg growth hormone with interval exercise |
| Name | Type | Description |
|---|---|---|
| Norditropin SimpleXx (growth hormone) | DRUG | 3mg/subject/day over two consecutive days |
Inclusion Criteria: * AGHD male or female subjects * Stable GH replacement therapy for at least 3 months * Body Mass Index 18,5 to 35.0 kg/m2 * Achieved final height * Age ≥ 18 years Exclusion Criteria: * Known or suspected allergy to trial product or components of the trial product * Subjects wi...