Efficacy and Safety of TAK-385 in the Treatment of Endometriosis
Efficacy and Safety of TAK-385 in the Treatment of Endometriosis
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.
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.
Inclusion Criteria:

 1. Premenopausal women

 2. The participants must have dysmenorrhea and pelvic pain associated with endometriosis.

 3. The participant has experienced a regular menstrual cycle.

 4. 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:

 1. Participants diagnosed with measurable uterine fibroids with the longest diameter of 3
 cm or larger

 2. Participants with lower abdominal pain due to irritable bowel syndrome or severe
 interstitial cystitis

 3. Participants with a previous or current history of thyroid dysfunction

 4. Participants with current or previous history of pelvic inflammatory disease

 5. Participants with positive PAP smear test result conducted

 6. Participants with a history of panhysterectomy or bilateral oophorectomy

 7. Participants judged by investigator to have marked abnormal uterine bleeding or
 anovulatory bleeding

 8. Participants with a previous or current history of a malignant tumor

 9. 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

 10. 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

 11. Participants who have been treated with bisphosphonate preparation

 12. 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

 13. Participants with non-diagnosable abnormal genital bleeding

 14. Participants with a previous or current history of osteoporosis, bone mass loss, or
 other metabolic bone diseases

 15. Participants with clinically significant cardiovascular disease or uncontrollable
 hypertension

 16. Participants judged by investigator to be inappropriate to participate in this study
 based on the 12-lead electrocardiogram (ECG) findings

 17. 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