At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 44 enrolled
Drug / intervention
Triptorelindrug
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.
An Open-label, Non-comparative, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Triptorelin Pamoate (Embonate) 22.5 mg 6-month Formulation in Patients Suffering From Central (Gonadotropin-dependent) Precocious Puberty
In Brief
A Phase 3 clinical trial evaluating Triptorelin for Central Precocious Puberty. Completed, enrolled 44 participants across 13 sites in 3 countries.
Detailed Summary
The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Precocious Puberty
CountriesChile, Mexico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartApr 2012
Primary CompletionAug 2013
Study CompletionJul 2014
TodayJul 2026
First PostedNov 9, 2011
Enrollment StartApr 1, 2012
Primary CompletionAug 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.6 years ago
Interventions
Triptorelindrug
Powder and solution for solution for injection