NCT00685906已完成1 期
A Randomised, Double-blind, Two-way Crossover Study to Determine the Effects of Co-administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®
研究概览
简要总结
The purpose of this study is to examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Females who are healthy, non-pregnant, not planning pregnancy within the study period, non-breast-feeding, and pre-menopausal
- •Either currently taking Nordette® which was well tolerated for at least two months prior to randomisation with no history of break-through bleeding, or, willing to take Nordette for 2 months prior to receiving the study drug
- •Females of child-bearing potential must be willing to use at least 1 additional medically approved non-hormonal barrier contraceptive method (for example, condom or diaphragm) that contains spermicide
排除标准
- •History of intolerance (e.g. adverse events) to any oral contraceptive or AZD6140
- •History of blood vessel or bleeding conditions that would make the volunteer more prone to bleeding
- •History or presence of significant medical problems
- •Women who are current smokers
研究组 & 干预措施
1
Experimental
干预措施: AZD6140 (Drug)
2
Active Comparator
干预措施: Levonorgestrel and Ethinyl Estradiol (Nordette®) (Drug)
结局指标
主要结局
Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®
时间窗: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
次要结局
- Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette®(At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.)
- Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette®(At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2.)
- Safety and tolerability of AZD6140 when co-administered with Nordette®(Screening through completion of the study)
研究者
研究点 (1)
Loading locations...
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