Status:
COMPLETED
A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
Lead Sponsor:
Takeda
Conditions:
Endometriosis
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participa...
Eligibility Criteria
Inclusion
- 1\. Participants who have completed TAK-385/CCT-101 study
Exclusion
- Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
- Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT01452685
Start Date
March 1 2012
End Date
December 1 2013
Last Update
May 8 2014
Active Locations (69)
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1
Nagoya, Aichi-ken, Japan
2
Chiba, Chiba, Japan
3
Funabashi-shi, Chiba, Japan
4
Ichihara-shi, Chiba, Japan