Back to resultsEfficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
Primary Purpose
Uterine Fibroids
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
TAK-385
TAK-385
TAK-385
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
- The participant is a premenopausal woman.
- The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
- The participant has experienced regular menstrual cycles
- The participant is diagnosed as menorrhagia
Exclusion Criteria:
- Participants with a screening Hb <8 g/dL
- Participants with a previous or current history of blood disorders
- Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
- 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 a previous or current history of pelvic inflammatory disease
- Participants with a positive PAP smear test result
- 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 a bisphosphonate preparation
- Participants with a previous or current history of severe hypersensitivity or severe allergy to 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
TAK-385 10 mg QD
TAK-385 20 mg QD
TAK-385 40 mg QD
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Decrease in menstrual blood loss
Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).
Secondary Outcome Measures
Decrease in menstrual blood loss
Blood loss will be assessed using PBAC
Decrease in menstrual blood loss
Blood loss will be assessed using PBAC
Amenorrhea
Amenorrhea will be assessed using PBAC
Amenorrhea
Amenorrhea will be assessed using PBAC
Amenorrhea
Amenorrhea will be assessed using PBAC
Change in menstrual blood loss
Change in menstrual blood loss measured by PBAC
Myoma Volume
Uterine Volume
Hemoglobin Concentration in Blood
Pain Symptom
Measured by Numerical Rating Scale.
Other Clinical Symptoms
Assessed by clinical laboratory tests
Quality of Life (QOL) Score
QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL)
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
Up to Week 12.
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
NCT01452659
Brief Title
Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
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 Uterine Fibroids
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (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 uterine fibroids.
Detailed Description
This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
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
216 (Actual)
8. Arms, Groups, and Interventions
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
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TAK-385
Intervention Description
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-385
Intervention Description
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-385
Intervention Description
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.
Primary Outcome Measure Information:
Title
Decrease in menstrual blood loss
Description
Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).
Time Frame
Week 12 (one menstrual cycle)
Secondary Outcome Measure Information:
Title
Decrease in menstrual blood loss
Description
Blood loss will be assessed using PBAC
Time Frame
Up to Week 6
Title
Decrease in menstrual blood loss
Description
Blood loss will be assessed using PBAC
Time Frame
Up to Week 12.
Title
Amenorrhea
Description
Amenorrhea will be assessed using PBAC
Time Frame
Week 12 (one menstrual cycle).
Title
Amenorrhea
Description
Amenorrhea will be assessed using PBAC
Time Frame
Up to Week 6.
Title
Amenorrhea
Description
Amenorrhea will be assessed using PBAC
Time Frame
Up to Week 12.
Title
Change in menstrual blood loss
Description
Change in menstrual blood loss measured by PBAC
Time Frame
Week 12 (one menstrual cycle)
Title
Myoma Volume
Time Frame
Up to Week 12.
Title
Uterine Volume
Time Frame
Up to Week 12.
Title
Hemoglobin Concentration in Blood
Time Frame
Up to Week 12.
Title
Pain Symptom
Description
Measured by Numerical Rating Scale.
Time Frame
Up to Week 12.
Title
Other Clinical Symptoms
Description
Assessed by clinical laboratory tests
Time Frame
Up to Week 12.
Title
Quality of Life (QOL) Score
Description
QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL)
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
Description
Up to Week 12.
Title
Laboratory Values
Time Frame
Up to Week 12
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:
The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
The participant is a premenopausal woman.
The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
The participant has experienced regular menstrual cycles
The participant is diagnosed as menorrhagia
Exclusion Criteria:
Participants with a screening Hb <8 g/dL
Participants with a previous or current history of blood disorders
Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
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 a previous or current history of pelvic inflammatory disease
Participants with a positive PAP smear test result
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 a bisphosphonate preparation
Participants with a previous or current history of severe hypersensitivity or severe allergy to 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Chiba-shi
State/Province
Chiba
Country
Japan
City
Itchihara-shi
State/Province
Chiba
Country
Japan
City
Matsuno-shi
State/Province
Chiba
Country
Japan
City
Matsuyama-shi
State/Province
Ehime
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
Yanagigawa-shi
State/Province
Fukuoka
Country
Japan
City
Mebashi-shi
State/Province
Gunma
Country
Japan
City
Ebetsu-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Amagasaki-shi
State/Province
Hyogo
Country
Japan
City
Kobe-shi
State/Province
Hyogo
Country
Japan
City
Kamakura-shi
State/Province
Kanagawa
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Oita-shi
State/Province
Oita
Country
Japan
City
Ibaraki-shi
State/Province
Osaka
Country
Japan
City
Osaka-shi
State/Province
Osaka
Country
Japan
City
Sakai-shi
State/Province
Osaka
Country
Japan
City
Tondabayashi-shi
State/Province
Osaka
Country
Japan
City
Chuo-ku
State/Province
Tokyo
Country
Japan
City
Itabashi-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
12. IPD Sharing Statement
Citations:
PubMed Identifier
34711224
Citation
Hoshiai H, Seki Y, Kusumoto T, Kudou K, Tanimoto M. Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial. BMC Womens Health. 2021 Oct 28;21(1):375. doi: 10.1186/s12905-021-01475-2.
Results Reference
derived
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Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
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