Uterine Fibroids
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 uterine fibroids.
Detailed description
This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.
Interventions
DRUGTAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
DRUGPlacebo
TAK-385 placebo-matching tablets, orally, once daily 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. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in menstrual blood loss | Week 12 (one menstrual cycle) | Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amenorrhea | Week 12 (one menstrual cycle). | Amenorrhea will be assessed using PBAC |
| Change in menstrual blood loss | Week 12 (one menstrual cycle) | Change in menstrual blood loss measured by PBAC |
| Myoma Volume | Up to Week 12. | — |
| Uterine Volume | Up to Week 12. | — |
| Hemoglobin Concentration in Blood | Up to Week 12. | — |
| Pain Symptom | Up to Week 12. | Measured by Numerical Rating Scale. |
| Other Clinical Symptoms | Up to Week 12. | Assessed by clinical laboratory tests |
| Quality of Life (QOL) Score | Up to Week 12. | QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL) |
| Decrease in menstrual blood loss | Up to Week 6 | Blood loss will be assessed using PBAC |
| 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). |
| Body Weight | Up to Week 12. | — |
| Electrocardiograms | — | Up to Week 12. |
| Laboratory Values | Up to Week 12 | — |
| 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 |
| Bone Mineral Density | Up to Week 12. | Measured by Dual-energy X-ray absorptiometry (DXA) |
Countries
Japan
Outcome results
None listed