NCT01452659已完成2 期
A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Uterine Fibroids
Takeda0 个研究点目标入组 216 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 主要终点
- Decrease in menstrual blood loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
TAK-385 10 mg QD
Experimental
干预措施: TAK-385 (Drug)
TAK-385 20 mg QD
Experimental
干预措施: TAK-385 (Drug)
TAK-385 40 mg QD
Experimental
干预措施: TAK-385 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Decrease in menstrual blood loss
时间窗: Week 12 (one menstrual cycle)
Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).
次要结局
- Amenorrhea(Up to Week 12.)
- Hemoglobin Concentration in Blood(Up to Week 12.)
- Serum BAP(Up to Week 12)
- Pain Symptom(Up to Week 12.)
- Quality of Life (QOL) Score(Up to Week 12.)
- Vital Signs(Up to Week 12.)
- Electrocardiograms
- Myoma Volume(Up to Week 12.)
- Bone Mineral Density(Up to Week 12.)
- Laboratory Values(Up to Week 12)
- Decrease in menstrual blood loss(Up to Week 12.)
- Uterine Volume(Up to Week 12.)
- Treatment-emergent Adverse Events(Up to Week 16.)
- Body Weight(Up to Week 12.)
- Change in menstrual blood loss(Week 12 (one menstrual cycle))
- Other Clinical Symptoms(Up to Week 12.)
- Serum NTx(Up to Week 12)
研究者
相似试验
已完成
2 期
Efficacy and Safety of TAK-385 in the Treatment of EndometriosisEndometriosisNCT01458301Takeda487
已完成
2 期
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral NeuropathyDiabetic NeuropathiesNCT00760955Takeda338
已完成
2 期
Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral NeuropathyDiabetic NeuropathiesNCT00229437Takeda343
已完成
2 期
A Long-term Extension Study of TAK-385 in the Treatment of EndometriosisEndometriosisNCT01452685Takeda397
已完成
2 期
Efficacy and Safety of TAK-875 in Combination With Sitagliptin in Participants With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01414920Takeda368