A Multicenter Study to Investigate the Efficacy and Safety of Daily Oral Administration of 2 mg Dienogest Tablets (Visanne/SH T00660AA) for the Treatment of Endometriosis in Chinese Patients: a Double-blind, Randomized, Placebo-controlled, Parallel Group Phase Over 24 Weeks Followed by an Open-label, Single-group Follow up Over 28 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 250
- 主要终点
- Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
研究概览
简要总结
This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the treatment of endometriosis.
There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28 weeks for all subjects who completed the double-blind phase, irrespective of their treatment assignment in the first study phase.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 45 years of age, inclusive
- •Women with endometriosis confirmed by laparoscopy or laparotomy within ten years but no later than 2 weeks before the Screening Visit
- •A score of at least 30 on a 100 mm visual analog scale (VAS) for endometriosis-associated pelvic pain at Screening Visit and Baseline Visit
- •Good general health (except for findings related to endometriosis, with or without infertility), as evidenced by medical history and complete physical and gynecological examination
- •Willingness to use a barrier method of contraception is required
排除标准
- •Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
- •Wish for pregnancy within intended treatment period
- •Before menarche or after menopause
- •Amenorrhea (more than three consecutive months in the six months before screening)
- •Undiagnosed abnormal genital bleeding
- •Previous/use of hormonal agents
- •Any disease or condition that may worsen under hormonal treatment
- •Signs and/or symptoms of therapy-resistant endometriosis despite more than one prior attempt at drug treatment or surgical therapy
- •Need for primary surgical treatment of endometriosis
- •Regular use of pain medication due to other underlying diseases
- •Contra-indication for the supportive analgesic medication (ibuprofen)
研究组 & 干预措施
Dienogest
50% of the participants will be randomized to this arm and will receive 2 mg dienogest (DNG) once daily by mouth from 0-52 weeks
干预措施: Dienogest (Visanne, BAY86-5258) (Drug)
Placebo
50% of the participants will be randomized to this arm and will receive placebo once daily by mouth from 0-24 weeks then switch to 2 mg dienogest (DNG) once daily by mouth from 25-52 weeks
干预措施: Dienogest (Visanne, BAY86-5258) (Drug)
Placebo
50% of the participants will be randomized to this arm and will receive placebo once daily by mouth from 0-24 weeks then switch to 2 mg dienogest (DNG) once daily by mouth from 25-52 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
时间窗: 24 weeks after baseline
次要结局
- Percentage of treatment responders(At 24 weeks)
- Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)(24 weeks after baseline)
- Quality of life assessed by patient questionnaire(Up to 24 weeks)
- Number of participants with adverse events as a measure of safety and tolerability(Up to 52 weeks)
- Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)(Up to 52 weeks)