Use of Somatropin in Turner Syndrome

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Genetic Disorder; Turner Syndrome

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518036

GHTUR/BPD/1

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome.

Enrollment: 57 patients

Sex: Female

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Turner Syndrome
• Not previously treated with growth hormone or androgen
• Well-documented height over the previous 12 months
• Informed consent of parents (and child if appropriate)

Exclusion criteria

• Growth hormone (GH) deficiency based on a GH stimulation test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Low dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

High dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin