The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Menstrual Cycle Length
研究概览
简要总结
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
详细描述
Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- •Age 18-35
- •Normal menstrual periods (24-35 days)
- •Good general health
- •Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence)
- •Willing and able to return to clinic for bi-weekly blood tests
排除标准
- •Pregnant or breast feeding
- •Polycystic ovarian disease
- •Gastrointestinal conditions (i.e.gastric ulcer)
- •Currently using birth control
- •Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs
- •Cardiac disease or hypertension
- •Moderate to severe heartburn (GERD)
- •Obesity (BMI greater than 30)
研究组 & 干预措施
1
干预措施: Celebrex (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Menstrual Cycle Length
时间窗: 3 months
Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.
次要结局
未报告次要终点
研究者
Alison Edelman
MD, MPH
Oregon Health and Science University