Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Genetic Disorder

Turner Syndrome

Eligibility:

FEMALE

2-11 years

Phase:

PHASE4

Brief Summary

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 heigh...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 1989

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2003

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT01518062

Start Date

November 1 1989

End Date

September 1 2003

Last Update

January 18 2017

Active Locations (1)

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1

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands