NCT01116440终止2 期
A Double Blind, Randomized, Controlled, Multicenter, Efficacy and Safety Study of Oral BGS649 vs. Placebo (Each Co-administered With a Combined Oral Contraceptive) Assessing Pain Response in Patients With Refractory Endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 44
- 主要终点
- Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
研究概览
简要总结
The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have surgical diagnosis of endometriosis est. w/in 5 years before screening. Subjects must have self reported moderate to severe pelvic pain at screening to be confirmed during the run-in-phase
- •Subjects with moderate to severe pelvic pain who were refractory to surgery (persistent or recurrent pelvic pain within 24 months after any therapeutic surgery) and at least two hormonal therapies from two different classes, including one approved hormonal therapy
排除标准
- •Subjects who have undergone hysterectomy or bilateral oophorectomy.
- •Surgical treatment of endometriosis within 3 months before screening.
- •Subjects who are pregnant or who were pregnant within 3 months of visit one.
- •Subjects who are nursing or lactating
- •Subjects who are tobacco smokers.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BGS649 co-administered with Levora 28™
Experimental
干预措施: BGS649 (Drug)
Placebo co-administered with Levora 28™
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
时间窗: 12 weeks
Mean change from baseline to Month 3 (Week 12) in Number Rating Scale pelvic pain score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine.
次要结局
- Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores(4 weeks)
- Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score(12 weeks)
- Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores(8 weeks)
- Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale(12 weeks)
研究者
研究点 (44)
Loading locations...
相似试验
Unknown
2 期
A Study To Evaluate the Safety, Tolerance, Pharmacokinetics/Pharmacodynamics and Efficacy of SYHA1402 Tablets For the Treatment of Patients With Diabetic Peripheral Neuropathy in ChinaDistal Symmetric Polyneuropathy (DSPN)NCT05116111CSPC ZhongQi Pharmaceutical Technology Co., Ltd.135
已完成
1 期
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)OsteoporosisNCT01011725Merck Sharp & Dohme LLC67
已完成
1 期
MAD Study of IA-14069HealthyRheumatoid ArthritisNCT05533372ILAb Co., Ltd.78
已完成
1 期
Study to Investigate LP352 in Subjects With Developmental and Epileptic EncephalopathiesDevelopmental and Epileptic EncephalopathyDravet SyndromeLennox Gastaut SyndromeNCT05364021Longboard Pharmaceuticals52
已完成
2 期
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant RecipientsNCT03663335Novartis Pharmaceuticals418