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

• Status: Completed
• Trial end date: 2012-09-01
• 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 uterine fibroids.

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

Details

• Lead Sponsor: Takeda
• Treatments: Relugolix

Criteria

Inclusion Criteria:

1. The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.

2. The participant is a premenopausal woman.

3. The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.

4. The participant has experienced regular menstrual cycles

5. The participant is diagnosed as menorrhagia

Exclusion Criteria:

1. Participants with a screening Hb <8 g/dL

2. Participants with a previous or current history of blood disorders

3. Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods

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

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

6. Participants with a previous or current history of pelvic inflammatory disease

7. Participants with a positive PAP smear test result

8. Participants with a history of panhysterectomy or bilateral oophorectomy

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

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

11. 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

12. 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

13. Participants who have been treated with a bisphosphonate preparation

14. Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs

15. Participants with non-diagnosable abnormal genital bleeding

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

17. Participants with clinically significant cardiovascular disease or uncontrollable hypertension

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

19. 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)