An Exploratory Study of a COX-2 Inhibitor(Meloxicam) for Prevention of Ovulation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Test the efficacy of meloxicam in preventing ovulation as measured by ovarian follicular development and delay in rupture when is administered daily for 18 days, starting on the 5th day of the cycle.
研究概览
简要总结
In this study the investigators propose to evaluate a COX-2 inhibitor(meloxicam) to assess its effect on follicular development and find out if this regimen delays or blocks ovulation while maintaining ovarian cyclicity. The investigators intend to administer 15 mg or 30 mg of meloxicam per day for 18 days starting on day 5 after onset of menses during 3 continuous cycles. The 3 treatment cycles will be preceded and followed by control cycles with no treatment. Ovulation or lack there of will be monitored by transvaginal ultrasound examinations (TVUs), estradiol, luteinizing hormone (LH), and progesterone levels in multiple blood samples in each cycle. The investigators will recruit a total of 56 women. Each woman will be randomly assigned to 1 of the 2 dose regimens of meloxicam, with 28 women assigned to each of the 2 dose regimens. Participating women will demonstrate an ovulatory cycle before starting meloxicam treatment and will be protected from pregnancy by prior sterilization.
详细描述
In a recent study, following follicular development by daily ultrasound examinations in 22 women, meloxicam was administered when the dominant follicle reached a diameter of 18 mm (Jesam, Salvatierra et al. 2010). Results from this study indicate that meloxicam 30 mg given for five days in late follicular phase was more effective at delaying follicular rupture than 15 mg. Follicular rupture was delayed more than 48 hours in 11/22 (50%) volunteers in the group treated with 15 mg/day and in 20/22 (91%) volunteers in the group treated with 30 mg/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Proven fertility in the past
- •18- 40 years old
- •Regular menstrual cycles in the past 3 months (24-35 days)
- •Surgically sterilized
- •Non-lactating
- •Hemoglobin of at least 11 g/dl
- •Willing to give informed consent in writing
排除标准
- •Allergy to meloxicam, aspirin, or other NSAIDs
- •Currently pregnant or breast feeding
- •History of gastrointestinal problems like stomach ulcer, bleeding or bowel problems
- •History of heart attack, stroke, or blood clot
- •Hemorrhagic or coagulation disorders
- •Known liver and renal disorder
- •History of or signs and symptoms of cancer, hyperprolactinemia, bloody breast discharge, diabetes, or any endocrine disturbance
- •History of asthma, skin or mucosal allergies
- •Hypertension: systolic blood pressure > 135 mm Hg or diastolic blood pressure >85 mmHg
- •History of mental illness including depression or epilepsy
- •Cigarette smoker
- •Habitual user of anti-inflammatory drugs
- •Alcoholism or any drug abuse
- •Use of anticoagulants or steroids
研究组 & 干预措施
meloxicam
15 mg versus 30 mg per day P.O for 15 days, during 3 menstrual cycles
干预措施: Meloxicam (Drug)
结局指标
主要结局
Test the efficacy of meloxicam in preventing ovulation as measured by ovarian follicular development and delay in rupture when is administered daily for 18 days, starting on the 5th day of the cycle.
时间窗: 3 menstrual cycles treated (3 months)
To assess follicular outcomes transvaginal ultrasound will be done to all participants during treatment cycles
次要结局
- Levels of progesterone(3 menstrual cycles (3 months))
- Levels of LH(3 menstrual cycles (3 months))
- Occurrence of functioning corpus luteum subsequent to unruptured follicles(3 menstrual cycles treated (3 months))
- Bleeding pattern during treatment with meloxicam(3 menstrual cycles treated (3 months))
- Pharmacokinetics of meloxicam(1 menstrual cycle (1 month))
- Incidence of adverse events(3 menstrual cycles treated (3 months))
- Levels of estradiol(3 menstrual cycles treated (3 months))