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 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 0