NCT01638923已完成3 期
A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 339
- 主要终点
- Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
研究概览
简要总结
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
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
- •Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception
- •Willingness to use barrier contraception (e.g., condoms) from screening to study completion
- •Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion
排除标准
- •Current diagnosis of organic uterine bleeding
- •History of endometrial ablation, or dilatation and curettage within 2 months of Visit
- •Clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound [TVU]).
- •Clinically significant abnormal results of breast examination (breast palpation).
- •Positive pregnancy test at Visit 1
- •Less than three months since delivery, abortion, or lactation before to start Visit 1
- •Other contraceptive methods
- •Any disease or condition that may worsen under hormonal treatment
- •Smokers over the age of 35
- •Body mass index >32
研究组 & 干预措施
Arm 1
Experimental
干预措施: EV/DNG (Qlaira, Natazia, BAY86-5027) (Drug)
Arm 2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
时间窗: 90 day baseline period and 90 days during treatment period
次要结局
- Proportion of subjects with successful treatment(90 days during treatment phase)
- Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)(Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7)
- Percent change of MBL at baseline and 90 day period during treatment phase(Baseline and 90 days during treatment phase)
- Proportion of subjects with improvement in the investigator's global assessment scale on Day 84(Treatment day 84)
- Number of participants with adverse events as a measure of safety and tolerability(Up to 12 months)
- Proportion of subjects with improvement in the investigator's global assessment scale on Day 196(Treatment day 196)
- Proportion of subjects with improvement in the subject's global assessment scale on Day 84(Treatment day 84)
- Proportion of subjects with improvement in the subject's global assessment scale on Day 196(Treatment day 196)
研究者
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