A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model
研究概览
简要总结
The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
详细描述
Pain caused by dysmenorrhea can range from mild to severe. At least 50% of all menstruating women experience appreciable pain at some time during their menstruation. An estimated 600 million work hours are lost annually to this affliction with an average loss of time of two or more workdays per year per female employee. Treatment of dysmenorrhea may include either non-pharmacological or pharmacological measures. Pharmacological treatments include oral contraceptives to treat hormonal imbalances, over-the-counter analgesics or non-steroidal anti-inflammatory drugs. The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation. This study aims to provide information on the safety and efficacy of the Vipon in a randomized controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females ages >= 18 years
- •4 consecutive monthly menstrual cycles
- •Self-assessment of dysmenorrhea
- •Non-pregnant status
- •Agrees to use adequate birth control during the trial
- •Consents to use tampons through the test of cure assessment
- •Provides informed consent for participating in the trial
排除标准
- •Prohibited use of pain medication 4 hours prior to treatment and during the first 2 hours after treatment with study medication
- •Positive pregnancy test
- •Unwilling or unable to comply with protocol
- •Allergic to ibuprofen
研究组 & 干预措施
Vipon
干预措施: Vipon (Device)
Ibuprofen
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model
时间窗: 1 month, 2 months, 3 months, 4 months
Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.
次要结局
未报告次要终点