EUCTR2016-004059-53-LV进行中（未招募）1 期
A Phase 3, multicentre, randomized, double-blind, placebo controlled study investigating the efficacy and safety of daily oral administration of OBE2109 alone and in combination with add-back therapy for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. - Primrose 2
相关药物
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
- 500
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
- •Premenopausal woman at screening
- •Body Mass Index = 18 kg/m2
- •Menstrual cycles = 21 days and = 40 days prior to screening
- •Presence of uterine fibroids
- •Heavy menstrual blood loss for the first eight days of two menstrual periods assessed at screening using the alkaline hematin method
- •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 500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the study
- •History of uterus surgery that would interfere with the study
- •The subject’s condition is so severe that she will require surgery within 6 months regardless of the treatment provided
- •Undiagnosed abnormal uterine bleeding
- •Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease
研究者
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