Completed
PHASE4
INTERVENTIONAL
NCT01562834
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.
Interventions
Name:
somatropin
Type:
DRUG
Description:
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.
Name:
placebo
Type:
DRUG
Description:
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.
Primary Outcomes
Measure:
Left ventricular mass measured with ultrasonography
TimeFrame:
Description:
Trial Information
NCT ID
NCT01562834
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025