Safety and Efficacy of Long-term Somatropin Treatment in Adults

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Interventions: Drug: somatropin

• Registration Number: NCT01543880
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-03-05
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 752

Inclusion Criteria

• In need of somatropin or current user

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Users of somatropin	somatropin	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Up to 10 years

Secondary Outcome Measures

Name	Time	Method
BMI (Body Mass Index)	Up to 10 years
IGF-I (Insulin-Like Growth Factor I)	Up to 10 years
HbA1c change	Up to 10 years