NCT01452659

Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Uterine Fibroids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.

Detailed description

This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	TAK-385	TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
DRUG	TAK-385	TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
DRUG	TAK-385	TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
DRUG	Placebo	TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-10-17
• Last updated: 2013-01-21

Locations

27 sites across 1 country: Japan