EUCTR2016-001736-35-PL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, phase 2b dose-ranging study to assess the efficacy and safety of OBE2109 in subjects with endometriosis associated pain. - EDELWEISS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ObsEva SA
- 入组人数
- 328
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •MAIN STUDY:
- •The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
- •The subject has moderate to severe endometriosis-associated pain during the screening period.
- •The subject has regular menstrual cycles.
- •The subject has a BMI = 18 kg/m2 at the screening visit.
- •EXTENSION PHASE:
- •The subject must have completed Parts A and B (24 weeks) treatment period in the main study.
- •The subject is willing and able to continue to comply with the requirements of the study protocol for the duration of the extension.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 330
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •MAIN STUDY:
- •The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
- •The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
- •The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
- •The subject has a history of, or known osteoporosis or other metabolic bone disease.
- •The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.
- •EXTENSION PHASE:
- •The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the extension.
- •The subject has at least one ovarian endometrioma with a diameter of 7 cm or greater.
- •The subject has BMD loss > 7% at either femoral neck, hip or spine or a Z-score = -2.5 on the Week 24 DXA Scan during the main study.
研究者
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