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Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01518062
First received: January 20, 2012
Last updated: January 17, 2017
Last verified: January 2017

January 20, 2012
January 17, 2017
November 1989
September 2003   (Final data collection date for primary outcome measure)
Final height
Same as current
Complete list of historical versions of study NCT01518062 on ClinicalTrials.gov Archive Site
  • Height velocity (cm/year)
  • Ratio between change in bone age and change in chronological age
  • Age at onset of puberty
  • Adverse events
Same as current
Not Provided
Not Provided
 
Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome
Dose Response Trial of Biosynthetic Authentic Human Growth Hormone and Induction of Puberty With 17b Oestradiol in Girls With Turner's Syndrome
This trial is conducted in Europe. The aim of this trial is to assess whether increasing doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and improve final height. This trial has two trial periods, a main period of 4 years and an extension period until final height is reached.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Genetic Disorder
  • Turner Syndrome
  • Drug: somatropin
    4 IU/m^2 body surface for 4 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
  • Drug: somatropin
    Initial dose 4 IU/m^2 body surface the first year, then 6 IU/m^2 body surface for 3 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
  • Drug: somatropin
    Initial dose 4 IU/m^2 body surface the first year, then 6 IU/m^2 body surface, the second year and finally 8 IU/m^2 body surface for 2 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
  • Drug: oestrogen
    Treatment with oestrogen was administered if spontaneous puberty had not occurred by age 12 years and was initiated in the extension period after at least four years of somatropin treatment
  • Experimental: Low dose
    Interventions:
    • Drug: somatropin
    • Drug: oestrogen
  • Experimental: Medium dose
    Interventions:
    • Drug: somatropin
    • Drug: oestrogen
  • Experimental: High dose
    Interventions:
    • Drug: somatropin
    • Drug: oestrogen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
September 2003
September 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Turner Syndrome
  • Well documented growth rate during the previous year
  • Height below the 50th percentile for the age in Dutch children
  • Normal thyroid function

Exclusion Criteria:

  • Any endocrine or metabolic disorder
  • Growth failure due to disorders of genitourinary, cardio-pulmonary, gastro-intestinal and nervous systems, nutritional/vitamins deficiencies and chondrodysplasias
  • Patients with hydrocephalus
Sexes Eligible for Study: Female
2 Years to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01518062
GHTUR/BPD/5-13
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP