Clinical trial: An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen (NCT00344383)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects in good health as confirmed by medical history, physical exam, and PAP smear
             within the preceding six months

          -  Non-smokers, if between 35 and 45 years of age

          -  Patients who are not pregnant or lactating

          -  Had at least one normal menstrual period within 35 days prior to screening

          -  Completed their last term pregnancy at least 42 days prior to screening and had at
             least one normal menstrual period since the last pregnancy

          -  Must be post-menarcheal (have had at least one normal menstrual period) and
             pre-menopausal (having regular menstrual periods)

        Exclusion Criteria:

          -  History or presence of disorders commonly accepted as contraindications to steroid
             hormonal therapy, eg, menopause, active or history of deep vein thrombophlebitis,
             thromboembolic disorders or hypercoagulation disorders, cerebral vascular or coronary
             artery disease, uncontrolled hypertension, or migraines with focal aura, benign or
             malignant liver tumor that developed during the use of oral contraceptives or
             estrogen-containing products

          -  carcinoma of any body system, diabetes mellitus with vascular involvement, known or
             suspected estrogen-dependent neoplasia, cholestatic jaundice, undiagnosed abnormal
             vaginal bleeding, neurovascular lesion of the eye, clinically relevant impairment of
             liver function, liver disease or renal disease

          -  absence of cyclic bleeding for at least three months, recent history of alcohol or
             other substance abuse

          -  significant depression or psychiatric disease that would result in an unreliable
             patients

          -  any subject deemed by the investigator to have questionable reliability in her ability
             to comply with the protocol and provide accurate information.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 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? Entailment