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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_4

Timeline

Completed

Started Oct 1998

Longer than P75 for phase_4

Geographic Reach

1 country

24 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

Study Start

First participant enrolled

October 21, 1998

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed

9.3 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.1 years

First QC Date

March 22, 2012

Last Update Submit

February 27, 2024

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

Left ventricular mass measured with ultrasonography

Secondary Outcomes (4)

Ventricular function indices assessed by cardiac ultrasonography
Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)
Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales
IGF-I (Insulin-Like Growth Factor I) concentration

Study Arms (2)

Somatropin

EXPERIMENTAL

Drug: somatropin

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

somatropinDRUG

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.

Somatropin

placeboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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
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

Contact the study team to confirm eligibility.