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

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: Placebo; Drug: TAK-385; Drug: Leuprorelin acetate

• Registration Number: NCT01452685
• Lead Sponsor: Takeda

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 participants from the Phase II dose-finding study (TAK-385/CCT-101 study).

Study Timeline

• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-17
• Study Start: 2012-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 397

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
TAK-385 10 mg QD	TAK-385	-
TAK-385 20 mg QD	TAK-385	-
TAK-385 40 mg QD	TAK-385	-
Leuplin	Leuprorelin acetate	-

Primary Outcome Measures

Name	Time	Method
Serum NTx	Up to Week 24	NTx is one of the biochemical bone metabolism markers
Serum BAP	Up to Week 24	BAP is one of the biochemical bone metabolism markers
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

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Score for Pelvic Pain	Up to Week 24	Pelvic pain will be assessed using the VAS as pain evaluation scale
VAS Score for Dyspareunia	Up to Week 24	Dyspareunia will be assessed using the VAS as pain evaluation scale