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

Uterine Fibroids Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01452659
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date October 2011
Completion date September 2012
View Details
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