Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome
Phase 4
Completed
- Conditions
- Turner SyndromeGenetic Disorder
- Interventions
- Drug: oestrogen
- Registration Number
- NCT01518062
- Lead Sponsor
- Novo Nordisk A/S
- 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 height. This trial has two trial periods, a main period of 4 years and an extension period until final height is reached.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose oestrogen - Low dose oestrogen - Medium dose oestrogen - Low dose somatropin - Medium dose somatropin - High dose somatropin -
- Primary Outcome Measures
Name Time Method Final height
- Secondary Outcome Measures
Name Time Method Ratio between change in bone age and change in chronological age Age at onset of puberty Adverse events Height velocity (cm/year)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇳🇱Alphen a/d Rijn, Netherlands