NCT02021097Unknown3 期
A Multicenter, Randomized, Open-labe, Controlled Study to Evaluate the Efficacy and Safety of the Combined Levonorgestrel(LNG) 100mcg and Ethinyl Estradiol(EE) 20mcg for Oral Contraception
Regenex Pharmaceutical, China0 个研究点目标入组 1,008 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,008
- 主要终点
- The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment
研究概览
简要总结
The purpose of this study is to evaluate the contraceptive efficacy and safety of an oral contraceptive containing a combination of LNG 100mcg/EE 20mcg compared to LNG 150mcg/EE 30 mcg.
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
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women,aged 20-35 years who wish to use a contraceptive.
- •Women without reproductive system infection complications.
- •Willingness to not use other forms of hormonal treatment.
- •Three regular menstrual cycles before the study(21-35 days per cycle with 3-7 day's bleeding period, without amenorrhea or irregular bleeding).
- •Signed informed consent prior to entry into the trial.
排除标准
- •Any contraindication to the use of oral contraceptives.
- •Vascular, metabolic, hepatic, renal, oncologic and other diseases.
研究组 & 干预措施
LNG100 mcg/EE20 mcg
Experimental
干预措施: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg (Drug)
LNG 150mcg/ EE 30mcg
Active Comparator
干预措施: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg (Drug)
结局指标
主要结局
The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment
时间窗: From fist dose to 13 treatment cycles (1 cycle=28 days)
次要结局
- Weight changes(From fist dose to 13 treatment cycles (1 cycle=28 days))
- Menstrual Cycle Control(From fist dose to 13 treatment cycles (1 cycle=28 days))
研究者
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