Growth Response in Girls With Turner Syndrome

Phase 4

Completed

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

• Registration Number: NCT01734486
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-09-23
• Primary Completion: 2003-05-21
• Study Completion: 2003-05-21
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-22
• Study First Posted: 2012-11-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• Turner syndrome
• If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
• If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
• Measured parental height available
• Written informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	somatropin	-
High dose	somatropin	-

Primary Outcome Measures

Name	Time	Method
Height gain in cm
Height gain, SDS (Standard Deviation Score)

Secondary Outcome Measures

Name	Time	Method
Bone maturation
Height

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 Vandoeuvre Les Nancy, France