A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Leuprolide; Relugolix

Criteria

Inclusion Criteria:

1. Participants who have completed TAK-385/CCT-101 study

Exclusion Criteria:

1. Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult

2. Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings

3. Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk

4. Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.