Clinical trial NCT01458301 (phase 2, status: completed)
Conditions: endometriosis
ICD codes: N80.8, N80.9, N80.0, N80.1, N80.5, N80.2, N80.3
Drugs: placebo, tak-385, tak-385, tak-385, leuprorelin acetate
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CONC(=O)NC1=CC=C(C=C1)C1=C(CN(C)C)C2=C(S1)N(CC1=C(F)C=CC=C1F)C(=O)N(C2=O)C1=CC=C(OC)N=N1, CONC(=O)NC1=CC=C(C=C1)C1=C(CN(C)C)C2=C(S1)N(CC1=C(F)C=CC=C1F)C(=O)N(C2=O)C1=CC=C(OC)N=N1, CONC(=O)NC1=CC=C(C=C1)C1=C(CN(C)C)C2=C(S1)N(CC1=C(F)C=CC=C1F)C(=O)N(C2=O)C1=CC=C(OC)N=N1, CC(O)=O
Eligibility 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