A Multi-center, Randomized, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Drospirenone] in the Patients With Endometriosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 312
- 主要终点
- Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)
研究概览
简要总结
This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase.
The primary objective of this study is to confirm the superiority of BAY86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.
The secondary objective is to investigate the long-term safety of BAY86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of BAY86-5300 when administered with an extended flexible regimen compared to dienogest.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as having endometriosis by laparotomy or laparoscopy, or by identification of chocolate cyst of endometriosis, or patients with the clinical diagnosis of endometriosis, who fulfill the condition of pelvic tenderness or induration of Cul-de-sac or uterine immobility
- •Patient with pelvic pain judged by the highest Visual Analogue Scale (VAS) value of 40 mm or higher which is determined during 2 menstrual cycles before randomization (baseline observation phase)
- •Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
- •Patients who do not wish to become pregnant during the course of the study
排除标准
- •Patients who have organic diseases of which surgical treatment is prioritized by investigator
- •Patients in whom any hormonal therapies, including combined oral contraceptives (COCs) and progestins, have failed for treatment of symptomatic endometriosis (moderate, severe pain)
- •Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
- •Patients for whom dienogest is contraindicated (according to Japanese labeling of Dinagest Tab 1mg)
研究组 & 干预措施
Arm 3
干预措施: Dienogest (Drug)
Arm 1
干预措施: EE20/DRSP(BAY86-5300) (Drug)
Arm 2
干预措施: Placebo (Drug)
结局指标
主要结局
Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)
时间窗: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)
The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)
次要结局
- Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)(Weeks 17-24 of treatment period)
- Average of pain(Weeks 17-24 of treatment period)
- Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)(Weeks 17-24 of treatment period)
- Dyspareunia(Weeks 17-24 of treatment period)
- Size of chocolate cyst(24 weeks after taking the initial study medication)
- Endometrial thickness(24 weeks after taking the initial study medication)
- Number of days with spotting/bleeding(Up to 52 weeks)