At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 37 enrolled
Drug / intervention
Triptorelin pamoate 11.25mg (Decapeptyl® SR)drug
Likely dose
Triptorelin pamoate 11.25mg (Decapeptyl® SR)from 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.
Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty
In Brief
A Phase 3 clinical trial evaluating Triptorelin pamoate 11.25mg (Decapeptyl® SR) for Precocious Puberty. Completed, enrolled 37 participants across 18 sites.
Detailed Summary
The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrecocious Puberty
CountriesFrance
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedNov 2007
Primary CompletionOct 2010
TodayJul 2026
First PostedNov 28, 2007
Enrollment StartOct 1, 2007
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 18.6 years ago
Interventions
Triptorelin pamoate 11.25mg (Decapeptyl® SR)drug
One intra muscular injection at day 1 and month 3.