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 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Contradiction