Back to resultsEfficacy and Safety 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:
- Premenopausal women
- The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
- The participant has experienced a regular menstrual cycle.
The participant has been diagnosed with endometriosis by method a), b), or c).
- Laparotomy
- Laparoscopy
- Chocolate cyst of the ovary confirmed by MRI
Exclusion Criteria:
- Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
- Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
- Participants with a previous or current history of thyroid dysfunction
- Participants with current or previous history of pelvic inflammatory disease
- Participants with positive PAP smear test result conducted
- Participants with a history of panhysterectomy or bilateral oophorectomy
- Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
- Participants with a previous or current history of a malignant tumor
- Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide,or denosumab
- Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
- Participants who have been treated with bisphosphonate preparation
- Participants with a previous or current history of hypersensitivity or allergy to Leuplin, synthetic LH-RH, LH-RH derivatives, gelatin-containing formulations or food containing gelatin, or have a previous or current history of severe hypersensitivity or severe allergy to other drugs
- Participants with non-diagnosable abnormal genital bleeding
- Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
- Participants with clinically significant cardiovascular disease or uncontrollable hypertension
- Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
- Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN) in the clinical laboratory tests
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
Score for pelvic pain as measured by the Visual Analogue Scale (VAS)
Pelvic pain will be assessed using the VAS as pain evaluation scale.
Secondary Outcome Measures
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
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.
Number of Participants with Markedly Abnormal Standard Safety Laboratory Values
Serum NTx
NTx is one of the biochemical bone metabolism markers
Serum BAP
BAP is one of the biochemical bone metabolism markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01458301
Brief Title
Efficacy and Safety of TAK-385 in the Treatment of Endometriosis
Official Title
A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 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 determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with endometriosis.
Detailed Description
This Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study will evaluate the efficacy and safety of 3 dose levels (10, 20, and 40 mg) of TAK-385 following oral administration for 12 weeks in women with endometriosis.
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
487 (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 injection, subcutaneously, once every 4 weeks for up to 12 weeks
Primary Outcome Measure Information:
Title
Score for pelvic pain as measured by the Visual Analogue Scale (VAS)
Description
Pelvic pain will be assessed using the VAS as pain evaluation scale.
Time Frame
Week 12 (one menstrual cycle)
Secondary Outcome Measure Information:
Title
VAS Score for Pelvic Pain
Description
Pelvic pain will be assessed using the VAS as pain evaluation scale
Time Frame
Up to Week 12.
Title
VAS Score for Dyspareunia
Description
Dyspareunia will be assessed using the VAS as pain evaluation scale
Time Frame
Up to Week 12.
Title
Bone Mineral Density
Description
Measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Up to Week 12.
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 12.
Title
Body Weight
Time Frame
Up to Week 12.
Title
Electrocardiograms.
Time Frame
Up to Week 12.
Title
Number of Participants with Markedly Abnormal Standard Safety 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 12.
Title
Serum BAP
Description
BAP is one of the biochemical bone metabolism markers
Time Frame
Up to Week 12.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal women
The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
The participant has experienced a regular menstrual cycle.
The participant has been diagnosed with endometriosis by method a), b), or c).
Laparotomy
Laparoscopy
Chocolate cyst of the ovary confirmed by MRI
Exclusion Criteria:
Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
Participants with a previous or current history of thyroid dysfunction
Participants with current or previous history of pelvic inflammatory disease
Participants with positive PAP smear test result conducted
Participants with a history of panhysterectomy or bilateral oophorectomy
Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
Participants with a previous or current history of a malignant tumor
Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide,or denosumab
Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
Participants who have been treated with bisphosphonate preparation
Participants with a previous or current history of hypersensitivity or allergy to Leuplin, synthetic LH-RH, LH-RH derivatives, gelatin-containing formulations or food containing gelatin, or have a previous or current history of severe hypersensitivity or severe allergy to other drugs
Participants with non-diagnosable abnormal genital bleeding
Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
Participants with clinically significant cardiovascular disease or uncontrollable hypertension
Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN) in the clinical laboratory tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Director
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
32912633
Citation
Osuga Y, Seki Y, Tanimoto M, Kusumoto T, Kudou K, Terakawa N. Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study. Fertil Steril. 2021 Feb;115(2):397-405. doi: 10.1016/j.fertnstert.2020.07.055. Epub 2020 Sep 7.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of TAK-385 in the Treatment of Endometriosis
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