CompletedPhase 3

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

France91 participantsStarted 2006-06

Plain-language summary

The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. 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. Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.

Who can participate

Age range8 Years – 171 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * male or female children with ISS * age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys * bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist * Pubertal stage B2 and B3 for girls based on the Tanner method * Pubertal stage G2 and G3 for boys based on the Tanner method Exclusion Criteria: * 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 * Small for gestational age (SGA) * Has reached menarche (had her first menstrual period) * Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to Growth Hormone treatment

What they're measuring

Number of Participants With One or More Drug-related Adverse Events

Timeframe: Baseline through End of Study (up to 9 years)

Adult Height Standard Deviation Score (SDS)

Timeframe: Baseline through End of Study (up to 9 years)

Trial details

NCT IDNCT00355030

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2016-08-10