A Randomized, Double-blind, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Two Different Doses of Vilaprisan (BAY1002670) Versus Placebo in Women With Symptomatic Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 8
- 试验地点
- 23
- 主要终点
- Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD])
研究概览
简要总结
The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis.
The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.
With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1
- •Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging
- •Moderate to severe endometriosis-associated pelvic pain (EAPP)
- •Adherence to screening period diary entries
- •Willingness to use only standardized pain medication if needed
- •Good general health (except for findings related to endometriosis)
- •Normal or clinically insignificant cervical cytology not requiring further follow-up
- •An endometrial biopsy performed at the screening phase without significant histological disorder
- •Use of an acceptable non-hormonal method of contraception
- •Willingness / ability to comply with electronic diary entry for the duration of study participation
排除标准
- •Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1)
- •Hypersensitivity to any ingredient of the study treatments
- •Laboratory values outside the inclusion range before randomization, and considered clinically relevant
- •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 including elevated liver enzymes
- •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •Undiagnosed abnormal genital bleeding
- •Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator
- •Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- •Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol
- •Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator
- •Inability to cooperate with the study procedures for any reason
- •Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias)
- •Hypersensitivity to any ingredient of standardized pain medication
- •Wish for pregnancy during the study
- •Regular use of pain medication due to other underlying diseases
- •Non-responsiveness of EAPP to GnRH-a (Gonadotropin-releasing hormone agonists)
研究组 & 干预措施
Vilaprisan (BAY1002670) 2 mg
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 2 mg
干预措施: Vilaprisan (BAY1002670) (Drug)
Vilaprisan (BAY1002670) 4 mg
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 4 mg
干预措施: Vilaprisan (BAY1002670) (Drug)
Placebo group
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD])
时间窗: Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean 'worst pelvic pain' was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.
次要结局
- Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) on Days With/Without Vaginal Bleeding(Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days))
- Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)(Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days))
- Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings(Up to 6 months)
- Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)(Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days))
- The Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to 6 months)
- Number of Participants With Clinical Significant Abnormal Ultrasound Examinations(Up to 6 months)
- Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements(Up to 6 months)
- Number of Participants With Clinical Significant Abnormal Laboratory Values(Up to 6 months)