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OpenTrials
Completed

NCT Number: NCT01518062

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

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Key information

Conditions

Genetic Disorder Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Male Urogenital Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Age range

2 year–11 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

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

oestrogen

Drug

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

Primary outcomes

  1. Final height

Secondary outcomes

  1. Height velocity (cm/year)

  2. Ratio between change in bone age and change in chronological age

  3. Age at onset of puberty

  4. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Dose Response Trial of Biosynthetic Authentic Human Growth Hormone and Induction of Puberty With 17b Oestradiol in Girls With Turner's Syndrome

Important dates

Study start
1989
Primary completion
2003
Study completion
2003
First posted
Jan 25, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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