Endometriosis
Conditions
Keywords
Drug Therapy
Brief 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.
Detailed description
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.
Interventions
DRUGPlacebo
TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
DRUGTAK-385
TAK-385 10 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks
DRUGLeuprorelin acetate
TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate injection, subcutaneously, once every 4 weeks for up to 12 weeks
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score for pelvic pain as measured by the Visual Analogue Scale (VAS) | Week 12 (one menstrual cycle) | Pelvic pain will be assessed using the VAS as pain evaluation scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Score for Dyspareunia | Up to Week 12. | Dyspareunia will be assessed using the VAS as pain evaluation scale |
| Bone Mineral Density | Up to Week 12. | Measured by Dual-energy X-ray absorptiometry (DXA) |
| Treatment-emergent Adverse Events. | Up to Week 16 | Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16) |
| Vital Signs | Up to Week 12. | Vital signs will include body temperature, sitting blood pressure and pulse (bpm). |
| VAS Score for Pelvic Pain | Up to Week 12. | Pelvic pain will be assessed using the VAS as pain evaluation scale |
| Electrocardiograms. | Up to Week 12. | — |
| Number of Participants with Markedly Abnormal Standard Safety Laboratory Values | Up to Week 24 | — |
| Serum NTx | Up to Week 12. | NTx is one of the biochemical bone metabolism markers |
| Serum BAP | Up to Week 12. | BAP is one of the biochemical bone metabolism markers |
| Body Weight | Up to Week 12. | — |
Countries
Japan
Outcome results
None listed