Back to resultsA Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Placebo
TAK-385
TAK-385
TAK-385
Leuprorelin acetate
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Drug Therapy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Other
Arm Label
Placebo
TAK-385 10 mg QD
TAK-385 20 mg QD
TAK-385 40 mg QD
Leuplin
Arm Description
Outcomes
Primary Outcome Measures
Bone Mineral Density
Measured by Dual-energy X-ray absorptiometry (DXA)
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)
Vital Signs
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
Body Weight
Electrocardiograms
Laboratory Values
Serum NTx
NTx is one of the biochemical bone metabolism markers
Serum BAP
BAP is one of the biochemical bone metabolism markers
Secondary Outcome Measures
Visual Analogue Scale (VAS) Score for Pelvic Pain
Pelvic pain will be assessed using the VAS as pain evaluation scale
VAS Score for Dyspareunia
Dyspareunia will be assessed using the VAS as pain evaluation scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01452685
Brief Title
A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
TAK-385 10 mg QD
Arm Type
Experimental
Arm Title
TAK-385 20 mg QD
Arm Type
Experimental
Arm Title
TAK-385 40 mg QD
Arm Type
Experimental
Arm Title
Leuplin
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-385
Intervention Description
TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-385
Intervention Description
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-385
Intervention Description
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Leuprorelin acetate
Other Intervention Name(s)
Leuplin
Intervention Description
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
Primary Outcome Measure Information:
Title
Bone Mineral Density
Description
Measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Up to Week 24.
Title
Treatment-emergent Adverse Events
Description
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)
Time Frame
Up to Week 16
Title
Vital Signs
Description
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
Time Frame
Up to Week 24
Title
Body Weight
Time Frame
Up to Week 24
Title
Electrocardiograms
Time Frame
Up to Week 24.
Title
Laboratory Values
Time Frame
Up to Week 24
Title
Serum NTx
Description
NTx is one of the biochemical bone metabolism markers
Time Frame
Up to Week 24
Title
Serum BAP
Description
BAP is one of the biochemical bone metabolism markers
Time Frame
Up to Week 24
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Score for Pelvic Pain
Description
Pelvic pain will be assessed using the VAS as pain evaluation scale
Time Frame
Up to Week 24
Title
VAS Score for Dyspareunia
Description
Dyspareunia will be assessed using the VAS as pain evaluation scale
Time Frame
Up to Week 24
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VP Clinical Science Strategy
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Nagoya-shi
State/Province
Aichi
Country
Japan
City
Chiba-shi
State/Province
Chiba
Country
Japan
City
Funabashi-shi
State/Province
Chiba
Country
Japan
City
Ichihara-shi
State/Province
Chiba
Country
Japan
City
Yachiyo-shi
State/Province
Chiba
Country
Japan
City
Nihama-shi
State/Province
Ehime
Country
Japan
City
Fukui-shi
State/Province
Fukui
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Iizuka-shi
State/Province
Fukuoka
Country
Japan
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
City
Onga-gun
State/Province
Fukuoka
Country
Japan
City
Yanagawa-shi
State/Province
Fukuoka
Country
Japan
City
Koriyama-shi
State/Province
Fukushima
Country
Japan
City
Takayama-shi
State/Province
Gifu
Country
Japan
City
Takasaki-shi
State/Province
Gunma
Country
Japan
City
Hirosima-shi
State/Province
Hirosima
Country
Japan
City
Ebetsu-shi
State/Province
Hokkaido
Country
Japan
City
Ishikari-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Amagasaki-shi
State/Province
Hyogo
Country
Japan
City
Kako-gun
State/Province
Hyogo
Country
Japan
City
Kawanishi-shi
State/Province
Hyogo
Country
Japan
City
Kobe-shi
State/Province
Hyogo
Country
Japan
City
Kanazawa-shi
State/Province
Ishikawa
Country
Japan
City
Marugame-shi
State/Province
Kagawa
Country
Japan
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
City
Hiratsuka-shi
State/Province
Kanagawa
Country
Japan
City
Kamakura-shi
State/Province
Kanagawa
Country
Japan
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
City
Yamato-shi
State/Province
Kanagawa
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Nankoku-shi
State/Province
Kochi
Country
Japan
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
City
Sendai-shi
State/Province
Miyagi
Country
Japan
City
Matsumoto-shi
State/Province
Nagano
Country
Japan
City
Nagano-shi
State/Province
Nagano
Country
Japan
City
Suzaka-shi
State/Province
Nagano
Country
Japan
City
Nara-shi
State/Province
Nara
Country
Japan
City
Oita-shi
State/Province
Oita
Country
Japan
City
Kurashiki-shi
State/Province
Okayama
Country
Japan
City
Okayama-shi
State/Province
Okayama
Country
Japan
City
Hirakata-shi
State/Province
Osaka
Country
Japan
City
Ibaraki-shi
State/Province
Osaka
Country
Japan
City
Ikeda-shi
State/Province
Osaka
Country
Japan
City
Osaka-shi
State/Province
Osaka
Country
Japan
City
Sakai-shi
State/Province
Osaka
Country
Japan
City
Suita-shi
State/Province
Osaka
Country
Japan
City
Tondabayashi-shi
State/Province
Osaka
Country
Japan
City
Toyonaka-shi
State/Province
Osaka
Country
Japan
City
Iruma-shi
State/Province
Saitama
Country
Japan
City
Kusatsu-shi
State/Province
Shiga
Country
Japan
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
City
Numazu-shi
State/Province
Shizuoka
Country
Japan
City
Yaizu-shi
State/Province
Shizuoka
Country
Japan
City
Komatsushima-shi
State/Province
Tokushima
Country
Japan
City
Naruto-shi
State/Province
Tokushima
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
City
Chuo-ku
State/Province
Tokyo
Country
Japan
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
City
Machida-shi
State/Province
Tokyo
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Ohta-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
City
Suginami-ku
State/Province
Tokyo
Country
Japan
City
Toyama-shi
State/Province
Toyama
Country
Japan
City
Yamaguchi-shi
State/Province
Yamaguchi
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34154590
Citation
Osuga Y, Seki Y, Tanimoto M, Kusumoto T, Kudou K, Terakawa N. Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in women with endometriosis-associated pain: phase 2 safety and efficacy 24-week results. BMC Womens Health. 2021 Jun 21;21(1):250. doi: 10.1186/s12905-021-01393-3.
Results Reference
derived
Learn more about this trial
A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
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