Use of Somatropin in Turner Syndrome

Phase 3

Completed

• Conditions: Genetic Disorder; Turner Syndrome
• Interventions: Drug: somatropin

• Registration Number: NCT01518036
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 1987-09-14
• Primary Completion: 2004-04-11
• Study Completion: 2004-04-11
• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

• Turner Syndrome
• Not previously treated with growth hormone or androgen
• Well-documented height over the previous 12 months
• Informed consent of parents (and child if appropriate)

Exclusion Criteria

• Growth hormone (GH) deficiency based on a GH stimulation test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	somatropin	-
Low dose	somatropin	-

Primary Outcome Measures

Name	Time	Method
Final height in cm

Secondary Outcome Measures

Name	Time	Method
Ratio between change in bone age and change in chronological age
Age at onset of puberty
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Crawley, United Kingdom