At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 115 enrolled
Drug / intervention
r-hGHdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Collaborative Study to Assess the Effects of Treatment With Recombinant Growth Hormone Saizen® in the Prevention of Short Stature in Young Girls Suffering From Turner Syndrome Before the Age of 4 Years. Original French Title: Etude Collaborative Pour apprécier Les Effets du Traitement Par l'Hormone de Croissance Recombinante SAIZEN® Dans le Retard de Croissance de la Fillette Atteinte de Syndrome de Turner Avant l'âge de 4 Ans
In Brief
A Phase 4 clinical trial evaluating r-hGH for Turner's Syndrome. Completed, enrolled 115 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the efficacy and safety of recombinant human growth hormone (r-hGH) treatment in girls with Turner Syndrome under the age of 4 years. After 4 years of treatment, height in these girls will be compared with an historical control group of untreated girls with Turner Syndrome, matched for age and height at baseline.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTurner's Syndrome
CountriesFrance
Collaborators--
Timeline
Phase 4CompletedFinished
199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 1992
Primary CompletionMar 1999
First PostedFeb 2010
Study CompletionAug 2010
TodayJul 2026
First PostedFeb 10, 2010
Enrollment StartFeb 29, 1992
Primary CompletionMar 31, 1999
Study CompletionAug 31, 2010
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 16.4 years ago
Interventions
r-hGHdrug
Subcutaneous administration.