Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01734447

Enrollment

Registered

2012-11-27

Start date

2000-04-30

Completion date

2003-04-30

Last updated

2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foetal Growth Problem, Small for Gestational Age

Brief summary

This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

Interventions

DRUGsomatropin

1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients born with IUGR enrolled in trial GHRETARD/F/1/F * Bone age below 14 years in boys and 12 years in girls

Exclusion criteria

* Bone age above 14 years in boys and 12 years in girls

Design outcomes

Primary

Measure	Time frame
Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion	—

Secondary

Measure	Time frame
Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray	—
Pubertal development, assessed according to Tanner method	—
Height velocity	—
Final height	—
Number of Adverse Events	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026