A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Mean Change in Average Severity for Abdominal/Pelvic Pain
研究概览
简要总结
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sexually naïve and agree to abstain from sex during the study
- •Moderate to severe menstrual-related pelvic pain
- •Regular spontaneous menstrual cycles
排除标准
- •Any contraindication to the use of oral contraceptives
- •Treatment with an oral contraceptive within the previous 3 months
- •Previous treatment failure with an extended oral contraceptive regimen
研究组 & 干预措施
1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet
干预措施: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets (Drug)
2
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Mean Change in Average Severity for Abdominal/Pelvic Pain
时间窗: Baseline to end of 13-week treatment period
Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")
次要结局
- Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain(Baseline to end of Week 13)
- Number of Days Missed From School/Work or Other Activities(13-week treatment period)
- Analgesic Use(13-week treatment period)
- Incidence of Menstrual Bleeding and /or Spotting(Baseline to end of Week 13)