NCT00824187已完成3 期
A Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Monophasic Oral Contraceptive YAZ (20 µg Ethinylestradiol, 3 mg Drospirenone) in the Treatment of Chinese Patients With Premenstrual Dysphoric Disorder (PMDD)
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
- 187
- 主要终点
- The difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days before menses of the 3rd cycle in the treatment phase to average scores from the last 5 days before menses of the 2 run in cycles
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).
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
- Double (Participant, Investigator)
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
- •Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)
排除标准
- •Any formal psychotherapeutic counselling within 1 month before the screening visit (Visit 1) or used medication for Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) including, but not limited to hormones, bromocriptine, GnRH agonists, vitamin B6 (>100 mg), calcium supplements (> 1500 mg/day), anxiolytics and antidepressants during the 3 month period prior to Visit 1
- •Use of sleeping medication (including melatonin) for more than 3 days per month.
- •Pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment
- •Obesity (body mass index or BMI > 30 kg/m2)
- •Hypersensitivity to any ingredient of the study drug
研究组 & 干预措施
Arm 1
Experimental
干预措施: EE20/DRSP(YAZ, BAY86-5300) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days before menses of the 3rd cycle in the treatment phase to average scores from the last 5 days before menses of the 2 run in cycles
时间窗: 3 cycles (1 cycle= 28 days)
次要结局
- The difference in DRSP scale scores for the 3 functional impairment items, comparing the average over the last 5 days of daily scores from the 3rd cycle in the treatment phase to the average of daily scores from the 2 run in cycles(3 cycles)
- Descriptive statistics for total DRSP scale scores (sum of the first 21 items) of the last 5 days for each of the 2 run in cycles, each of the 3 cycles in the treatment phase, and the average of the 3 cycles in the treatment phase(3 cylces)
- Descriptive statistics for change in total DRSP scale scores (sum of the first 21 items) of the last 5 days from baseline to each cycle in the treatment phase and to the average of the 3 cycles in the treatment phase(3 cycles)
- Assessment of CGI scores(3 cycles)
- Adverse events(Whole study period)
- Laboratory tests(Whole study period)
研究者
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