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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

22 participants in 2 patient groups, including a placebo group

Somatropin
Experimental group
Treatment:
Drug: somatropin
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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