NCT02655224

A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called relugolix (TAK-385). Relugolix is being tested to treat people who have uterine fibroids. The study enrolled 65 patients. Participants received relugolix placebo in run in period for 3 to 6 weeks. After run-in period, participants were randomly assigned to one of the two treatment groups in 1:1 ratio: 1. Relugolix 40 mg 2. Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants were asked to take one tablet at the same time each day throughout the study. This multi-center trial was conducted in Japan. The overall time to participate in this study was 20 to 28 weeks, including run-in period of 3 to 6 weeks and a treatment period of 12 weeks. Participants made multiple visits to the clinic, and 4 weeks after last dose of study drug for a follow-up assessment.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Relugolix	Relugolix Tablets
DRUG	Relugolix placebo	Relugolix placebo-matching tablets

Timeline

• Start date: 2016-03-26
• Primary completion: 2017-05-16
• Completion: 2017-05-19
• First posted: 2016-01-13
• Last updated: 2019-03-22
• Results posted: 2019-03-22

Locations

11 sites across 1 country: Japan