Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Leuprolide; Relugolix

Criteria

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