Clinical trial: The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function (NCT00128726)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy women of legal age of consent between 18-35 years who wish to use a continuous
             combined oral contraceptive and are non-smokers.

          -  Must have a regular (25-31) day menstrual cycle for the three month period preceding
             enrollment.

          -  Subject will comply with protocol, in the opinion of the investigator.

        Exclusion Criteria:

          -  Thrombophlebitis

          -  Known or suspected clotting disorders

          -  Cerebrovascular or coronary artery disease or myocardial infarction

          -  Malignancy

          -  Known or suspected estrogen dependent neoplasia

          -  Undiagnosed abnormal genital bleeding

          -  Benign or malignant liver tumor that developed during the use of oral contraceptives
             or other estrogen-containing products

          -  Hyperlipidemia - fasting cholesterol level greater than 6.73 mmol/L (260mg); fasting
             triglyceride level greater than 3.39 mmol/L (300mg/dl); high cholesterol.

          -  Diabetes mellitus

          -  Migraine or increased sensitivity of headaches during previous estrogen or oral
             contraceptive study

          -  Depression requiring hospitalization or associated with suicidal ideation

          -  Chronic renal disease

          -  Known hypersensitivity to estrogens and/or progestogens

          -  Neuro-ocular disorders

          -  Cholestatic jaundice

          -  Pregnancy while taking oral contraceptives

          -  Persistent non compliance with taking medication

          -  Serious adverse experiences with oral contraceptive use

          -  Malabsorption due to illness or surgery

          -  Use of any experimental drug or device within the last 90 days before study drug
             administration

          -  Any anticonvulsant medications

          -  Any use of rifampin within 3 months of enrollment

          -  Any use of lipid lowering agents

          -  Impaired liver function or disease

          -  Known or suspected pregnancy

          -  Hypertension whether treated or untreated

          -  Cervical cytological smear or low grade squamous intraepithelial lesion (SIL) or
             greater that is untreated within the last year

          -  The use of an intrauterine device (IUD) or injectable or implantable estrogen,
             progestogens, or androgens during the six month period before enrollment; or oral
             contraceptive or sex hormone use within three cycles before enrollment.

          -  Breast feeding

          -  Known or suspected alcoholism or drug abuse

          -  Smoking
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 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