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

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Estradiol; Estrogens

Criteria

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