An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Versus Standard of Care
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 1,272
- 试验地点
- 219
- 主要终点
- Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine
研究概览
简要总结
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
- •At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
- •Good general health
- •Normal or clinically insignificant cervical smear
- •An endometrial biopsy performed during the screening period, without significant histological disorder
- •Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
排除标准
- •Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- •Hypersensitivity to any ingredient of the study drug
- •Any condition requiring immediate blood transfusion
- •Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
- •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •Abuse of alcohol, drugs, or medicines (eg, laxatives)
- •Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- •Undiagnosed abnormal genital bleeding
研究组 & 干预措施
A1(3/1 regimen)
2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
干预措施: Vilaprisan (BAY1002670) (Drug)
A2(6/2 regimen)
2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
干预措施: Vilaprisan (BAY1002670) (Drug)
A3(3/2 regimen)
2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
干预措施: Vilaprisan (BAY1002670) (Drug)
B(Standard of care)
Standard of care as determined by the investigators, this could be watch & wait or non-hormonal medical treatment
干预措施: Standard of care (Other)
结局指标
主要结局
Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine
时间窗: From baseline to about 1 year after start of treatment
The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.
次要结局
- Number of Bleeding Days(Treatment phase: approximately 1 year)
- Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)(Up to 3 years (from study treatment start to end of study))
- Change From Baseline in Endometrial Thickness(Treatment phase: approximately 1 year, follow-up phase: up to 2 years)
- Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck(Treatment phase: approximately 1 year, follow-up phase: up to 2 years)