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

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.

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)