Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
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.
Inclusion Criteria:

 1. Person is over the age of 20 but not older than age 45.

 2. Person is willing to participate as evidenced by signing the written informed consent
 form.

 3. Suffers from known dominant severe symptom of breast swelling and tenderness (level
 7-10 according to standard scale of PMS symptoms severity)

 4. 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.

 5. At work, school, home, or in daily routine, at least one of the PMS symptoms caused
 reduction of productivity or inefficiency

 6. At least one of the PMS symptoms caused avoidance of or less participation in hobbies
 or social activities

 7. 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.

 Exclusion Criteria:

 1. Pregnant or lactating woman

 2. Oral contraceptives during last three months, including hormonal IUD (trade name
 mirena).

 3. Serious health problems.

 4. Unexplained menstrual disorders.

 5. Treated by hormones (estrogen and progesterone).

 6. For healthy: Irregular or abnormal test results.