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

Condition(s) targeted: Premenstrual Syndrome

Intervention: Skin test panel (Drug); Skin test panel (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: EVE Medical Systems Ltd.

Official(s) and/or principal investigator(s):
Avner Reshef, Dr., Principal Investigator, Affiliation: Allergy and clinical Immunology Department

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

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Primary outcome: 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

Secondary outcome: Minimal skin test related adverse events.

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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.

Yonit Bomstein, Dr., Phone: +972-54-7889917, Email: ybomstein@evepms.com

Sheba Medical Center, Tel-Hashomer, Ramat Efal 52621, Israel; Recruiting
Avner Reshef, Dr, Phone: +972-3-5302605, Email: Avner.Reshef@sheba.health.gov.il
Iris Leibovich, Phone: +972-3-5302605, Email: iris.leibovich@sheba.health.gov.il
Avner Reshef, Dr, Principal Investigator

EVE's technology

Starting date: April 2009
Last updated: June 15, 2010