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

NCT01518062 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-01-18

No results posted yet for this study

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.

Conditions

  • Genetic Disorder
  • Turner Syndrome

Interventions

DRUG

somatropin

4 IU/m\^2 body surface for 4 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection

DRUG

somatropin

Initial dose 4 IU/m\^2 body surface the first year, then 6 IU/m\^2 body surface for 3 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection

DRUG

somatropin

Initial dose 4 IU/m\^2 body surface the first year, then 6 IU/m\^2 body surface, the second year and finally 8 IU/m\^2 body surface for 2 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection

DRUG

oestrogen

Treatment with oestrogen was administered if spontaneous puberty had not occurred by age 12 years and was initiated in the extension period after at least four years of somatropin treatment

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1989-11-30
Primary Completion
2003-09-30
Completion
2003-09-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518062 on ClinicalTrials.gov