NCT00787878

Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects

Comparison of Safety in Small for Gestational Age (SGA) Subjects Treated With Norditropin® (Somatropin) 5 Years Ago With Untreated SGA Subjects and With Normal Average for Gestational Age (AGA) Subjects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects.

Conditions

• Foetal Growth Problem
• Small for Gestational Age

Interventions

Type	Name	Description
DRUG	somatropin	SGA previously treated with Norditropin®
DRUG	No treatment given	Untreated SGA
DRUG	No treatment given	AGA (Average gestational age)

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-11-10
• Last updated: 2017-01-18

Locations

1 site across 1 country: Netherlands