At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 65 enrolled
Drug / intervention
Relugolix +1 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, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-385 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids
In Brief
A Phase 3 clinical trial evaluating Relugolix and Relugolix placebo for Uterine Fibroids. Completed, enrolled 65 participants across 11 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of Relugolix (TAK-385) in patients having pain symptoms associated 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 CompletionMay 2017
TodayJul 2026
First PostedJan 13, 2016
Enrollment StartMar 26, 2016
Primary CompletionMay 16, 2017
Study CompletionMay 19, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.5 years ago
Interventions
Relugolixdrug
Relugolix Tablets
Relugolix placebodrug
Relugolix placebo-matching tablets