Use of Somatropin in 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

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

1987-09-14

Study Completion Date

2004-04-11

Brief Summary

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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.

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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

2.9 IU/m\^2/day. Administered as once daily subcutaneous injection until final height is reached

High dose

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

4.3 IU/m\^2/day. Administered as once daily subcutaneous injection until final height is reached

Interventions

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somatropin

2.9 IU/m\^2/day. Administered as once daily subcutaneous injection until final height is reached

Intervention Type DRUG

somatropin

4.3 IU/m\^2/day. Administered as once daily subcutaneous injection until final height is reached

Intervention Type DRUG

Eligibility Criteria

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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)