Clinical trial: Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals (NCT00700128)

Eligibility criteria:
Inclusion Criteria:

          -  Woman may be on birth control pill (OC), patch or NuvaringTM (vaginal ring) taken in
             the traditional 21/7 or 24/4 manner, which means ever month they have a period. If
             they are taking it continuously (without a period), you must be willing to take your
             birth control 24/4 (4 days taking hormone free interval, HFI) for 2 months.

          -  If you are not on OCs, patch or NuvaringTM you must have a period every 21-40 days.

          -  You must not want to get pregnant for 12 months.

          -  Women have headaches around the time of their period.

        Exclusion Criteria:

          -  BMI > 38

          -  If you smoke and are age 35 years old or greater or if are under 35 years old and
             smoke over 10 cigarettes a day

          -  If you have or had an aura with your headaches (An aura is a temporary sensation, like
             bright lights that come before you experience the headache.)

          -  Headaches are not occurring during the time of your period.

          -  Blood Pressure > 140/90 or you take more than a single antihypertensive medication
             (excluding diuretics) and are age 40 or greater.

          -  Contraindications to combination estrogen/progestin hormonal contraception.

          -  Desire to become pregnant in the next 12 months.

          -  Refuse to avoid any ergot-based medication, triptan medication or isometheptene/midrin
             during their hormone free interval or the one day before the hormone free interval

          -  Stroke

          -  Breast Cancer

          -  Blood clots in your legs, lung or anywhere else in your body

          -  Diabetes mellitus

          -  Heart attack

          -  Liver disease

          -  Lupus Erythematosus
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction