Use of Somatropin in Turner Syndrome

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: January 20, 2012
Last updated: July 10, 2012
Last verified: July 2012
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio between change in bone age and change in chronological age [ Designated as safety issue: No ]
  • Age at onset of puberty [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: September 1987
Study Completion Date: April 2004
Primary Completion Date: April 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


Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01518036

United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Christian B. Djurhuus Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01518036     History of Changes
Other Study ID Numbers: GHTUR/BPD/1 
Study First Received: January 20, 2012
Last Updated: July 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 May 25, 2016