Clinical trial: Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel (NCT00866437)

Eligibility 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.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction