A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 120
- 主要终点
- Amenorrhea (yes/no)
研究概览
简要总结
The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, 18 to 50 years of age at the time of screening
- •Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >/=3.0 cm
- •Heavy menstrual bleeding (HMB) >80 mL documented by menstrual pictogram (MP) in a bleeding episode during the screening period. Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, e.g. with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures. Women suffering from perceived HMB despite medical treatment, e.g. with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior medication are followed. Heavy menstrual bleeding /HMB) > 80 mL should be documented within 10 consecutive days.
- •Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results
- •Normal or clinically insignificant cervical smear not requiring further follow-up. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
- •An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.
- •Use of an acceptable nonhormonal method of contraception (i.e. either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study. This is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s).
排除标准
- •Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- •Uterine fibroid with largest diameter >10.0 cm
- •Hypersensitivity to any ingredient of the study drugs
- •Hemoglobin values </= 6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values </=10.9 g/dL will be offered iron supplementation).
- •Any diseases or conditions 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 (e.g. 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
Arm 7- Ulipristal + Placebo
Ulipristal 5 mg once daily (12 weeks), treatment break, Placebo once daily (12 weeks)
干预措施: Ulipristal (Drug)
Arm 1 - BAY1002670 + BAY1002670
Vilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
干预措施: Vilaprisan (BAY1002670) (Drug)
Arm 2 - Placebo + BAY1002670
Placebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
干预措施: Vilaprisan (BAY1002670 (Drug)
Arm 3 - BAY1002670 + BAY1002670
Vilaprisan 2 mg once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily (12 weeks)
干预措施: Vilaprisan (BAY1002670 (Drug)
Arm 4 - Placebo+BAY1002670
Placebo once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily(12 weeks)
干预措施: Vilaprisan (BAY1002670) (Drug)
Arm 5 - Ulipristal + Ulipristal
Ulipristal 5 mg once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
干预措施: Ulipristal (Drug)
Arm 6- Placebo + Ulipristal
Placebo once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
干预措施: Ulipristal (Drug)
结局指标
主要结局
Amenorrhea (yes/no)
时间窗: From day 7 to day 84 of treatment.
Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period.
次要结局
- Number of bleeding days(Up to 32 weeks)
- Time to onset of controlled bleeding(Up to 28 weeks)
- Percent change in volume of largest fibroid from baseline to end of treatment.(Baseline and up to 28 weeks)
- Endometrial thickness measured by transvaginal ultrasound.(Baseline and up to 40 weeks)
- Endometrial histology(Baseline and up to 40 weeks)