At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 66 enrolled
Drug / intervention
Triptorelin Pamoatedrug
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.
A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty.
In Brief
A Phase 3 clinical trial evaluating Triptorelin Pamoate for Central Precocious Puberty. Completed, enrolled 66 participants across 14 sites.
Detailed Summary
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Precocious Puberty
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartAug 2021
First PostedAug 2021
Primary CompletionAug 2022
Study CompletionFeb 2023
TodayJul 2026
First PostedAug 31, 2021
Enrollment StartAug 10, 2021
Primary CompletionAug 21, 2022
Study CompletionFeb 13, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.8 years ago
Interventions
Triptorelin Pamoatedrug
Triptorelin 6-month formulation for IM on day 1 and Month 6.