The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase
研究概览
简要总结
The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.
详细描述
A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2). Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the above treatment schemes and received the other in the subsequent treatment cycle.
This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib, would be a more effective agent in terms of causing ovulatory dysfunction. This study also aims to determine whether treatment with celecoxib would adversely affect luteal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Currently NOT using hormonal contraception
- •Cycle length between 26-34 days
- •General good health (specifically no hx of: diabetes, cardiac problems, moderate/severe heart burn (GERD), obesity (BMI > 30), hypertension (BP > 130/80)
- •Willing and able to agree to randomization and informed consent
- •Willing and able to use a menstrual diary to chart bleeding Serum progesterone > 3 ng/ml (from cycle day 18-25)
- •Willing and able to return to clinic for bi-weekly for blood tests and ultrasounds throughout cycles 2, 3 & 5
排除标准
- •Cardiac disease
- •Moderate to severe heart burn (or GERD) Obesity (BMI > 30) Hypertension (BP > 130/80)
- •Allergy to NSAIDS
- •Currently pregnant or trying to conceive
- •Polycystic Ovarian Syndrome
- •Use of hormonal contraception (participants can use barrier methods, spermicide, female or male sterilization, copper intrauterine device, abstinence, or have female partners
研究组 & 干预措施
Pre-LH surge celecoxib administration
Pre-LH surge dosing of celecoxib
干预措施: Celebrex (Drug)
Pre-LH surge celecoxib administration
Pre-LH surge dosing of celecoxib
干预措施: Placebo (Drug)
Post-LH surge celecoxib administration
Post-LH surge dosing of celecoxib
干预措施: Celebrex (Drug)
Post-LH surge celecoxib administration
Post-LH surge dosing of celecoxib
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase
时间窗: 4 cycles (approximately 4 months)
One cycle corresponds to one participant
次要结局
- Peak Estradiol Level(4 cycles (approximately 4 months))
- Peak Hormone Levels(4 cycles (approximately 4 months))
研究者
Alison Edelman
Assistant Professor SM.OB/GYN Generalist Division
Oregon Health and Science University