Prospective, Controlled, Single-blinded, Longitudinal, Two-arms, Clinical Study Evaluation of Efficacy/Safety of EVE-PMS Skin-Test Panel -Detecting Sensitivity to Sex Hormones in Women With Premenstrual Syndrome
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- EVE-PMS Skin-Test Panel can obtain statistically significant sensitivity & specificity to support the diagnosis of PMS, particularly in women with severe symptoms(i.e. breast swelling; tenderness; other PMS symptoms according to widely accepted criteria
研究概览
简要总结
The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS).
The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Person is over the age of 20 but not older than age
- •Person is willing to participate as evidenced by signing the written informed consent form.
- •Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity)
- •Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may include one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity.
- •At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency
- •At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities
- •At least one of the PMS symptoms interfere with relationships with others:
- •i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow.
- •ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days.
- •iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms.
- •iv. Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle.
- •v. Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms.
- •vi. Reliable non hormonal contraception.
排除标准
- •Pregnant or lactating woman
- •Oral contraceptives during last three months, including hormonal IUD (trade name mirena).
- •Serious health problems.
- •Unexplained menstrual disorders.
- •Treated by hormones (estrogen and progesterone).
- •For healthy: Irregular or abnormal test results.
研究组 & 干预措施
Healthy Control group
干预措施: Skin test panel (Drug)
PMS
干预措施: Skin test panel (Drug)
结局指标
主要结局
EVE-PMS Skin-Test Panel can obtain statistically significant sensitivity & specificity to support the diagnosis of PMS, particularly in women with severe symptoms(i.e. breast swelling; tenderness; other PMS symptoms according to widely accepted criteria
时间窗: Total study duration will be approximately 2-3 months
次要结局
- Minimal skin test related adverse events.(2-3 Months)