Clinical trial: Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females (NCT00745901)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy females who want oral contraception

          -  No cervical or vaginal abnormalities on gynecological examination

          -  Negative Chlamydia test

          -  Pap smear without evidence of moderate or severe dysplasia or any malignancy within
             the preceding 12 months

          -  Negative urine pregnancy test conducted during Visit 1

          -  One normal menstrual period in 35 days prior to Visit 1

          -  Regular menstrual cycles (every 26-35 days)

          -  Last term pregnancy at least 42 days prior to Visit 1, and have had at least one
             normal menstrual period (typical in duration and amount of flow for the subject) since
             her last pregnancy

          -  Post-menarcheal and pre-menopausal

          -  At least one normal menstrual period (typical in duration and amount of flow for the
             subject) since having undergone uterines urgery or removal of an IUD, Norplant,
             DepoProvera or other hormonal injectables or implants.

        Exclusion Criteria:

          -  History or presence of disorders commonly accepted as contraindications to steroid
             hormonal therapy

          -  Previously discontinued ORTHO TRI-CYCLEN LO or YAZ due to breakthrough bleeding

          -  Pregnant or lactating

          -  Body mass index (BMI) of >40kg/m2

          -  Clinical evidence of carcinoma or other malignancy (history of basal cell carcinoma of
             the skin is not exclusionary)

          -  History of alcohol or drug abuse in the investigator's judgment based on history and
             physical examination (within 12 months prior to Visit 1)

          -  Significant depression or psychiatric disease in the investigator's judgment based on
             history and physical examination which would result in an unreliable patient

          -  Patient deemed by the investigator to have questionable reliability in her ability to
             comply with the protocol and provide accurate information

          -  Have any medical condition or planned surgical procedure which, in the opinion of the
             investigator, may be exacerbated by treatment with study medication or a patient
             receiving any concurrent therapy that could be affected by treatment with study
             medication

          -  Disallowed therapies: currently taking therapeutic anticoagulants (e.g,. Coumadin,
             Heparin) or have a bleeding disorder (e.g. von Willebrand's Disease), DepoProvera or
             other hormonal injectables in the six months before Visit 1, currently have Norplant
             or other hormonal implants in place, or have had removal of Norplant within 60 days
             prior to Visit 1, used a steroid-containing IUD within 3 months prior to Visit 1

          -  Or current use of an IUD

          -  Consistently elevated blood pressure defined as sitting systolic BP>140 mmHg or
             diastolic BP>90 mmHg

          -  Have an untreated thyroid disorder in the investigator's judgment based on history and
             physical examination

          -  unable to swallow solid, oral dosage forms whole with the aid of water (participants
             may not chew, divide, dissolve, or crush the study drug)

          -  Patients who in the opinion of the investigator should not be enrolled in the study
             based on the product labeling for ORTHO TRI-CYCLEN LO and YAZ including potential
             drug-drug interactions

          -  Have received an experimental drug or used an experimental medical device within 30
             days before the planned start of treatment
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? 0