Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature

What Was Tested

The trial (phase 3) is built around Leuprolide.

However, treatments were stopped in January 2012 at the request of the French drug agency.

Therefore, a protocol amendment divided the study in two study periods.

It had two arms (groups): 1 (experimental) and 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 91 actual participants took part.

It was open to people of any sex aged from 8 years up to 171 months.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female children with ISS. Pubertal stage B2 and B3 for girls based on the Tanner method. Pubertal stage G2 and G3 for boys based on the Tanner method.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: growth hormone deficiency (ghd); insulin-like growth factor-i levels greater than 3 sds; chromosomal abnormality diagnosed locally on a karyotype. for girls, the karyotype to eliminate a turner syndrome, is mandatory.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2006-06 with completion listed for 2015-07.

It ran at 19 sites in France (17) and Netherlands (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With One or More Drug-related Adverse Events (time frame: Baseline through End of Study (up to 9 years)). Adult Height Standard Deviation Score (SDS) (time frame: Baseline through End of Study (up to 9 years)).

It also tracked 7 secondary outcomes, for example Height Velocity, Height SDS, Difference Between Adult Height SDS and Target Height SDS, Difference Between Adult Height SDS and Baseline Predicted Height SDS, Difference Between Adult Height SDS and Baseline Height SDS and Percentage of Children With Normal Adult Height SDS.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 91 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.