Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Growth Response in Girls With Turner Syndrome

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: November 22, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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) [ Designated as safety issue: No ]
  • Height gain in cm [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height [ Designated as safety issue: No ]
  • Bone maturation [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: September 1996
Study Completion Date: May 2003
Primary Completion Date: May 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


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT01734486

TOULOUSE cedex, France, 31059
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Bruno Baron Novo Nordisk Pharmaceutique SAS
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S Identifier: NCT01734486     History of Changes
Other Study ID Numbers: GHTUR/F/3
Study First Received: November 22, 2012
Last Updated: November 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Turner Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Chromosome Disorders
Congenital Abnormalities
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Pathologic Processes
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities processed this record on November 20, 2014