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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Placebo
* Drug: TAK-385
* Drug: TAK-385
* Drug: TAK-385
* Drug: Leuprorelin acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Participants who have completed TAK-385/CCT-101 study Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.<br>|
| Experimental: TAK-385 10 mg QD<br> | Drug: TAK-385<br>* TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.<br>|
| Experimental: TAK-385 20 mg QD<br> | Drug: TAK-385<br>* TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.<br>|
| Experimental: TAK-385 40 mg QD<br> | Drug: TAK-385<br>* TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.<br>|
| Other: Leuplin<br> | Drug: Leuprorelin acetate<br>* TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks<br>* Other names: Leuplin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density | Measured by Dual-energy X-ray absorptiometry (DXA) | Up to Week 24. | 
| Treatment-emergent Adverse Events | 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) | Up to Week 16 | 
| Vital Signs | Vital signs will include body temperature, sitting blood pressure and pulse (bpm). | Up to Week 24 | 
| Body Weight |  | Up to Week 24 | 
| Electrocardiograms |  | Up to Week 24. | 
| Laboratory Values |  | Up to Week 24 | 
| Serum NTx | NTx is one of the biochemical bone metabolism markers | Up to Week 24 | 
| Serum BAP | BAP is one of the biochemical bone metabolism markers | Up to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) Score for Pelvic Pain | Pelvic pain will be assessed using the VAS as pain evaluation scale | Up to Week 24 | 
| VAS Score for Dyspareunia | Dyspareunia will be assessed using the VAS as pain evaluation scale | Up to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy