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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Genetic Disorder; Turner Syndrome

Treatments: Drug: oestrogen; Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518062

GHTUR/BPD/5-13

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Female

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Low dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

Drug: somatropin

Drug: oestrogen

Medium dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

Drug: somatropin

Drug: oestrogen

High dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

Drug: somatropin

Drug: oestrogen