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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

1989-11-30

Study Completion Date

2003-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Genetic Disorder Turner Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

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

oestrogen

Intervention Type DRUG

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

Medium dose

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

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

oestrogen

Intervention Type DRUG

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

High dose

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

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

oestrogen

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No