Endometriosis
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Premenopausal women 2.The participants must have dysmenorrhea and pelvic pain associated with endometriosis. 3.The participant has experienced regular menstrual cycle. 4.The participant has been diagnosed with endometriosis by method a), b), or c). a) Laparotomy b) Laparoscopy c) Chocolate cyst of the ovary confirmed by MRI
Exclusion criteria
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 a previous or current 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score for pelvic pain as measured by the Visual Analogue Scale (VAS) Pelvic pain will be assessed using the VAS as pain evaluation scale. Timeframe:At baseline and the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score for pelvic pain and VAS score for dyspareunia Pelvic pain and dyspareunia will be assessed using the VAS. Timeframe:At baseline and during treatment period | — |
Outcome results
None listed