Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients

Novo Nordisk

Status and phase

Completed

Phase 4

Conditions

Adult Growth Hormone Deficiency

Growth Hormone Disorder

Treatments

Drug: placebo

Drug: somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01562834

GHDADULT/F/1/F

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Childhood or adult onset growth hormone deficiency (GHD)
GHD evidenced by two stimulation tests
Duration of GHD at least 5 years
Other hormone deficiencies associated with growth hormone deficiency

Exclusion criteria

Pregnancy or pregnancy desired during the suggested duration of the study
Personal history of colonic polyp or family history of colonic polyposis
Known insulin-dependent or non-insulin-dependent diabetes
Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment
BMI (Body Mass Index) at least 30
Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy
Patient who has participated in a different clinical study within the past two months
Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study
Notion of breast cancer for the mother or the sister