CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 290 enrolled
Drug / intervention
LY01005 3.6 mg +1 moredrug
Likely dose
LY01005 3.6 mgfrom 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/NCT04563936
NCT04563936Phase 3Completed
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A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in Patients With Prostate Cancer

Luye Pharma Group Ltd.·interventional·Posted Sep 25, 2020·Updated Aug 26, 2021

In Brief

A Phase 3 clinical trial evaluating LY01005 3.6 mg and ZOLADEX® 3.6 mg for Prostate Cancer. Completed, enrolled 290 participants across 1 site.

Detailed Summary

This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 25, 2020
Enrollment StartJan 6, 2020
Primary CompletionMar 9, 2021
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 5.8 years ago

Interventions

LY01005 3.6 mgdrug

LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.

ZOLADEX® 3.6 mgdrug

ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.