Status:
COMPLETED
Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
Lead Sponsor:
Takeda
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
- The participant is a premenopausal woman.
- The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
- The participant has experienced regular menstrual cycles
- The participant is diagnosed as menorrhagia
Exclusion
- Participants with a screening Hb \<8 g/dL
- Participants with a previous or current history of blood disorders
- Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
- Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
- Participants with a previous or current history of thyroid dysfunction
- Participants with a previous or current history of pelvic inflammatory disease
- Participants with a positive PAP smear test result
- Participants with a history of panhysterectomy or bilateral oophorectomy
- Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
- Participants with a previous or current history of a malignant tumor
- 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
- 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
- Participants who have been treated with a bisphosphonate preparation
- Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs
- Participants with non-diagnosable abnormal genital bleeding
- Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
- Participants with clinically significant cardiovascular disease or uncontrollable hypertension
- Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01452659
Start Date
October 1 2011
End Date
September 1 2012
Last Update
January 21 2013
Active Locations (27)
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1
Chiba, Chiba, Japan
2
Itchihara-shi, Chiba, Japan
3
Matsuno-shi, Chiba, Japan
4
Matsuyama, Ehime, Japan