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Use of Somatropin in Turner Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518036
First Posted: January 25, 2012
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Genetic Disorder Turner Syndrome Drug: somatropin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Norditropin® in Turner's Syndrome

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Final height in cm

Secondary Outcome Measures:
  • Ratio between change in bone age and change in chronological age
  • Age at onset of puberty
  • Adverse events

Enrollment: 57
Actual Study Start Date: September 14, 1987
Study Completion Date: April 11, 2004
Primary Completion Date: April 11, 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose Drug: somatropin
2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
Experimental: High dose Drug: somatropin
4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518036


Locations
United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
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: NCT01518036     History of Changes
Other Study ID Numbers: GHTUR/BPD/1
First Submitted: January 20, 2012
First Posted: January 25, 2012
Last Update Posted: February 28, 2017
Last Verified: February 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