Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

Study Overview
=================
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.

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

Conditions
-----------------
Uterine Fibroids

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


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-385 10 mg QD<br> | Drug: TAK-385<br>* TAK-385 10 mg, tablets, orally, once daily 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 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 for up to 12 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in menstrual blood loss | Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC). | Week 12 (one menstrual cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in menstrual blood loss | Blood loss will be assessed using PBAC | Up to Week 6 | 
| Decrease in menstrual blood loss | Blood loss will be assessed using PBAC | Up to Week 12. | 
| Amenorrhea | Amenorrhea will be assessed using PBAC | Week 12 (one menstrual cycle). | 
| Amenorrhea | Amenorrhea will be assessed using PBAC | Up to Week 6. | 
| Amenorrhea | Amenorrhea will be assessed using PBAC | Up to Week 12. | 
| Change in menstrual blood loss | Change in menstrual blood loss measured by PBAC | Week 12 (one menstrual cycle) | 
| Myoma Volume |  | Up to Week 12. | 
| Uterine Volume |  | Up to Week 12. | 
| Hemoglobin Concentration in Blood |  | Up to Week 12. | 
| Pain Symptom | Measured by Numerical Rating Scale. | Up to Week 12. | 
| Other Clinical Symptoms | Assessed by clinical laboratory tests | Up to Week 12. | 
| Quality of Life (QOL) Score | QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL) | Up to Week 12. | 
| Bone Mineral Density | Measured by Dual-energy X-ray absorptiometry (DXA) | Up to Week 12. | 
| 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 12. | 
| Body Weight |  | Up to Week 12. | 
| Electrocardiograms | Up to Week 12. |  | 
| Laboratory Values |  | Up to Week 12 | 
| Serum NTx | NTx is one of the biochemical bone metabolism markers | Up to Week 12 | 
| Serum BAP | BAP is one of the biochemical bone metabolism markers | Up to Week 12 | 

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