NCT01569113已完成4 期
A Prospective, Randomized, Double-blind Parallel-arm, Placebo-controlled Study to Assess the Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® (Ulipristal Acetate 30 mg) or Placebo.
HRA Pharma3 个研究点 分布在 3 个国家目标入组 76 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Proportion of subjects with a Hoogland score consistent with ovarian quiescence (≤3) after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).
研究概览
简要总结
The purposes of this study are to compare the effects on ovarian activity of quick starting a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women aged 18-35 years old
- •BMI < 30 Kg/m2
- •Not at risk of pregnancy
- •No use of progesterone-only-pill for 3 months before start of treatment cycle
- •No use of implant hormonal contraception for 3 months before start of treatment cycle
- •No use of levonorgestrel intrauterine system for 3 months before start of treatment cycle
- •No use of depo provera for 12 months before start of treatment cycle
- •Able to give informed consent.
排除标准
- 未提供
研究组 & 干预措施
placebo + microgynon 30
Placebo Comparator
干预措施: placebo + ethinylestradiol/levonorgestrel (Drug)
ellaOne + microgynon 30
Experimental
干预措施: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) (Drug)
结局指标
主要结局
Proportion of subjects with a Hoogland score consistent with ovarian quiescence (≤3) after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).
时间窗: Day 1 to day 21 of intake of microgynon 30
次要结局
- Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.(Day 1 to day 21 of intake of microgynon 30)
研究者
研究点 (3)
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