A Single-Center, Randomized, Controlled, Double-Blind Feasibility Study Designed to Assess the Safety Performance of ActiLady Prototype in Adult Female Subjects With Dysmenorrhea.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To evaluate the safety of a novel method and device called ActiLady.
研究概览
简要总结
ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-35 years
- •Regular menstrual cycles (26-35 days); average duration of menstruation ≥5 days for the 4 months preceding the beginning of the trial.
- •Dysmenorrhea pain score >50mm on a 100mm visual analog scale (VAS) for the maximum abdominal pain
- •Analgesic use during every menstrual cycle
- •Non-pregnant, with no intentions to get pregnant during the clinical trial
- •Agrees not to use oral contraceptives or an intrauterine device (IUD) during the trial period
- •Agrees not to use analgesics, except during permitted period (16:00-04:00 the next day, daily)
- •Consents to the use of pads or other vaginal devices throughout the trial period
- •Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
- •Signed written informed consent form (ICF) to participate in the study
排除标准
- •Pregnant or lactating women
- •Used hormonal and/or oral contraceptives in the preceding 4 months
- •Use of an IUD in the preceding 4 months
- •Previous diagnosis of secondary dysmenorrhea
- •Urinary incontinence
- •Duration of menstruation is <5 days
- •Subjects with a known sensitivity to mechanical vibrations and/or silicone
- •Participation in current or recent clinical trial within 30 days prior to baseline visit
研究组 & 干预措施
Miniature Actilady device active
one miniature Actilady device tested for all patients during a 4 months period. The device is active in 3 months out of the 4, and the patients are blinded to the action of the device (sham comparator).
干预措施: Miniature Actilady device active (Device)
Miniature Actilady device not active
Sham Comparator: one miniature Actilady device tested for all patients during a 4 months period. The device is active in 3 months out of the 4, and the patients are blinded to the action of the device (sham comparator).
干预措施: Miniature Actilady device not active (Device)
结局指标
主要结局
To evaluate the safety of a novel method and device called ActiLady.
时间窗: 6 months
次要结局
- * Evaluate the pain-reducing effect of ActiLady on dysmenorrhea. * Study the relationship between menses flux and dysmenorrhea. [Time Frame: 6 months] [Designated as safety issue: No ] * Optimize treatment procedure and wave form.(6 months)
研究者
Ezra Yosi
Prof. Yossi Ezra
Hadassah Medical Organization