NCT01458301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 Endometriosis
Takeda0 个研究点目标入组 487 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
- 487
- 主要终点
- Score for pelvic pain as measured by the Visual Analogue Scale (VAS)
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 endometriosis.
详细描述
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.
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
- •Premenopausal women
- •The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
- •The participant has experienced a regular menstrual cycle.
- •The participant has been diagnosed with endometriosis by method a), b), or c).
- •Laparotomy
- •Laparoscopy
- •Chocolate cyst of the ovary confirmed by MRI
排除标准
- •Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
- •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 current or previous history of pelvic inflammatory disease
- •Participants with positive PAP smear test result conducted
- •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 bisphosphonate preparation
- •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
- •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) in the clinical laboratory tests
研究组 & 干预措施
TAK-385 40 mg QD
Experimental
干预措施: TAK-385 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
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)
Leuplin
Other
干预措施: Leuprorelin acetate (Drug)
结局指标
主要结局
Score for pelvic pain as measured by the Visual Analogue Scale (VAS)
时间窗: Week 12 (one menstrual cycle)
Pelvic pain will be assessed using the VAS as pain evaluation scale.
次要结局
- VAS Score for Pelvic Pain(Up to Week 12.)
- VAS Score for Dyspareunia(Up to Week 12.)
- Bone Mineral Density(Up to Week 12.)
- Treatment-emergent Adverse Events.(Up to Week 16)
- Vital Signs(Up to Week 12.)
- Body Weight(Up to Week 12.)
- 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.)
- Serum BAP(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 Uterine FibroidsUterine FibroidsNCT01452659Takeda216
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