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 Endometriosis

NCT01458301 Phase 2 COMPLETED

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

Details

Lead sponsor	Takeda
Phase	Phase 2
Status	COMPLETED
Enrolment	487
Start date	2011-10
Completion	2013-08

Conditions

• Endometriosis

Interventions

• Placebo
• TAK-385
• TAK-385
• TAK-385
• Leuprorelin acetate

Primary outcomes

• Score for pelvic pain as measured by the Visual Analogue Scale (VAS) — Week 12 (one menstrual cycle)
  Pelvic pain will be assessed using the VAS as pain evaluation scale.

Countries

Japan