CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Triptorelin Pamoate PR 3-month +1 moredrug
Likely dose
Triptorelin Pamoate PR 3-month 15mgfrom 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.

Search/NCT03232281
NCT03232281Phase 3Completed
CompareCT.gov

A Phase III, Multicentre, Randomised, Open-label, Parallel, Active-controlled Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis

Ipsen·interventional·Posted Jul 27, 2017·Updated Oct 14, 2021

In Brief

A Phase 3 clinical trial evaluating Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month for Endometriosis. Completed, enrolled 300 participants across 24 sites.

Detailed Summary

To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in Chinese female subjects with endometriosis by demonstrating the non-inferiority of triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate PR 1-month formulation injected 3 times consecutively.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 27, 2017
Enrollment StartJul 28, 2017
Primary CompletionMay 17, 2019
Study CompletionNov 16, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.9 years ago

Interventions

Triptorelin Pamoate PR 3-monthdrug

15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).

Triptorelin Acetate PR 1-monthdrug

3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)