Growth Response in Girls With Turner Syndrome

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Genetic Disorder; Turner Syndrome

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01734486

GHTUR/F/3

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.

Enrollment: 31 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Turner syndrome
• If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
• If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
• Measured parental height available
• Written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Low dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

High dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin