At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 281 enrolled
Drug / intervention
Relugolix +3 moredrug
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 Multicenter, Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-385 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
In Brief
A Phase 3 clinical trial evaluating Relugolix, Relugolix Placebo, and 2 other interventions for Uterine Fibroids. Completed, enrolled 281 participants across 25 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously \[SC\]/time) in patients with uterine fibroids.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartMar 2016
Primary CompletionMay 2017
Study CompletionSep 2017
TodayJul 2026
First PostedJan 13, 2016
Enrollment StartMar 5, 2016
Primary CompletionMay 17, 2017
Study CompletionSep 25, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.5 years ago
Interventions
Relugolixdrug
Relugolix tablets
Relugolix Placebodrug
Relugolix placebo-matching tablets
Leuprorelindrug
Leuprorelin injection
Leuprorelin Placebodrug
Leuprorelin placebo-matching injections