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Growth Response in Girls With Turner Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01734486
First received: November 22, 2012
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Genetic Disorder Turner Syndrome Drug: somatropin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Height gain, SDS (Standard Deviation Score)
  • Height gain in cm

Secondary Outcome Measures:
  • Height
  • Bone maturation

Enrollment: 31
Actual Study Start Date: September 23, 1996
Study Completion Date: May 21, 2003
Primary Completion Date: May 21, 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose Drug: somatropin
0.9 UI/kg/week. Subcutaneous injection for 3 years
Experimental: High dose Drug: somatropin
1.8 UI/kg/week. Subcutaneous injection for 3 years

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734486

Locations
France
Novo Nordisk Investigational Site
Besancon, France, 25030
Novo Nordisk Investigational Site
Bordeaux, France, 33000
Novo Nordisk Investigational Site
Dunkerque, France, 59385
Novo Nordisk Investigational Site
Grenoble, France, 38043
Novo Nordisk Investigational Site
Lille, France, 59037
Novo Nordisk Investigational Site
Lorient, France
Novo Nordisk Investigational Site
NICE cedex 3, France, 06202
Novo Nordisk Investigational Site
Paris, France
Novo Nordisk Investigational Site
Reims, France
Novo Nordisk Investigational Site
Rennes, France, 35056
Novo Nordisk Investigational Site
Rouen, France, 76031
Novo Nordisk Investigational Site
Tarbes, France
Novo Nordisk Investigational Site
TOULOUSE cedex, France, 31059
Novo Nordisk Investigational Site
Tours, France, 37044
Novo Nordisk Investigational Site
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01734486     History of Changes
Other Study ID Numbers: GHTUR/F/3
Study First Received: November 22, 2012
Last Updated: February 27, 2017

Additional relevant MeSH terms:
Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 21, 2017