Completed
PHASE3
INTERVENTIONAL
NCT00909844
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.
Interventions
Name:
Triptorelin (I.N.N.)
Type:
DRUG
Description:
Decapeptyl® SR 11.25mg
Primary Outcomes
Measure:
Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)
TimeFrame:
Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)
Description:
The primary objective was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of children maintaining a regression or stabilisation of sexual maturity (based on Tanner breast \[girls\] or genital \[boys\] pubertal stage) until end of study. Study treatment lasted until end of the therapeutic period; visits for Months 36 and 48 were optional since a child may have already finished the study at a prior visit. The Final Visit only occurred if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Results are presented only for percentage of girls with regression or stabilisation of Tanner breast pubertal stage (n=34). Since only one boy was included in the study, results for this outcome measure were listed only and no statistical analysis was performed. Please also note additional post-hoc analysis for regression or stabilisation of Tanner breast pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.
Trial Information
NCT ID
NCT00909844
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Ipsen
Last Updated
December 15, 2025