Status:
UNKNOWN
Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
Lead Sponsor:
EVE Medical Systems Ltd.
Conditions:
Premenstrual Syndrome
Eligibility:
FEMALE
20-45 years
Phase:
PHASE2
Brief Summary
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 pan...
Eligibility Criteria
Inclusion
- Person is over the age of 20 but not older than age 45.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00866437
Start Date
April 1 2009
End Date
November 1 2010
Last Update
June 16 2010
Active Locations (1)
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1
Sheba Medical Center, Tel-Hashomer
Ramat Efal, Israel, 52621