Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Skin test panel
  • Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators. Hormones: Progesterone 1mmol/L Estradiol 1mmol/L Estrone 3mmol/L Estriol 3mmol/l Controls: Saline (NaCl) 0.9% Ethyl Oleate with 10% Benzyl Alcohol Histamine phosphate 1mg/ml (epicutaneous- prick test)
• Drug: Skin test panel
  • Hormones: Progesterone 1mmol/L Estradiol 1 mmol/L Estrone 3 mmol/L Estriol 3mmol/l Controls: Saline (NaCl) 0.9% Ethyl Oleate with 10% Benzyl Alcohol Histamine phosphate 1mg/ml (epicutaneous- prick test)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Healthy Control group
• Experimental: PMS

Primary Measures

• 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
  • Time Frame: Total study duration will be approximately 2-3 months
    Safety Issue?: Yes

Secondary Measures

• Minimal skin test related adverse events.
  • Time Frame: 2-3 Months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: EVE Medical Systems Ltd. Industry

Overall Clinical Trial Officials and Contacts

Avner Reshef, Dr. Principal Investigator Allergy and clinical Immunology Department  

Overall Contact: Yonit Bomstein, Dr. +972-54-7889917 ybomstein@evepms.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00866437

Study ID Number: EveMS-0908

ClinicalTrials.gov Identifier: NCT00866437

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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