NCT01107093已完成2 期
A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge
HRA Pharma2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Inhibition of follicular rupture
研究概览
简要总结
Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:
- echographic follicle rupture
- inhibition of follicle rupture
- luteal phase progesterone levels
- anovulatory progesterone levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double
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
- •Women of good general health aged 18 - 35 years
- •Not at risk of pregnancy
- •Regular menstrual cycles of 24-35 days duration
- •Not pregnant
- •Intact uterus and ovaries
- •Haemoglobin ≥ 11 g/dl
- •Normal laboratory tests and normal TSH
- •Willing to abstain from any use of hormonal contraception until study completion
- •No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception
- •Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion
- •Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles
排除标准
- •Current participation in any other trial of an investigational medicine
- •Known hypersensitivity to the ingredients of the test active substances or excipients
- •Suspected hyperplasia or carcinoma of the endometrium
- •Current pregnancy as confirmed by positive serum beta-hCG at screening
- •Desire to get pregnant before the planned end of the study participation
- •Currently breastfeeding
- •Abnormal Pap smear
- •Cancer (past history of any carcinoma or sarcoma)
- •Known or suspected alcoholism or drug abuse
- •Abnormal thyroid status
- •Body mass index > 32
- •Current use of hormonal contraception
- •Use of hormonal emergency contraception since last menstrual period
- •Severe asthma insufficiently controlled by oral glucocorticoids
- •Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CDB-2914
Active Comparator
干预措施: CDB-2914 (ulipristal acetate) (Drug)
结局指标
主要结局
Inhibition of follicular rupture
时间窗: within 6 days after treatment intake
Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment
次要结局
- Appearance or absence of a corpus luteum(during the 6 days following treatment intake)
- Growth pattern of leading follicle
- Presence or absence of a surge of serum luteinizing hormone (LH) levels
- Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length
- Incidence of intermenstrual bleeding and treatment-emergent adverse events
- Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline
- Incidence of ovarian cysts after CDB-2914 treatment
研究者
研究点 (2)
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