A Phase II, Multicenter, Long-term Extension Study to Compare the Safety and Efficacy of TAK-385 (10, 20, and 40 mg) Following Oral Administration for 12 Weeks or More in the Treatment of Endometriosis

NCT01452685 Phase 2 COMPLETED

The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.

Details

Lead sponsor	Takeda
Phase	Phase 2
Status	COMPLETED
Enrolment	397
Start date	2012-03
Completion	2013-12

Conditions

• Endometriosis

Interventions

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

Primary outcomes

• Bone Mineral Density — Up to Week 24.
  Measured by Dual-energy X-ray absorptiometry (DXA)
• Treatment-emergent Adverse Events — Up to Week 16
  Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
• Vital Signs — Up to Week 24
  Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
• Body Weight — Up to Week 24
• Electrocardiograms — Up to Week 24.
• Laboratory Values — Up to Week 24

Countries

Japan