Clinical trial: Application for the Etonogestrel/Ethinyl Estradiol Ring (NCT03120728)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy, women ages 18 to 39yo with BMI <30

          -  Regular menstrual cycles with duration between 24-35 days

          -  Completion of screening visit where ovulation will be assessed with blood draw for
             progesterone level (must be 5ng/mL or greater)

          -  Not seeking pregnancy during the study period

          -  Use of a non-hormonal form of contraception, such as: sterilization (tubal ligation,
             Essure), copper IUD (intrauterine device), barrier methods or abstinence

          -  Must speak English or Spanish

        Exclusion Criteria:

          -  Currently pregnant or breastfeeding

          -  Severe pelvic organ prolapse or prolapse to any degree that may prevent retention of
             the vaginal ring after insertion

          -  Use of oral contraceptive pills, patches, implants or hormonal intrauterine
             contraception in the month prior to screening

          -  Use of depo medroxyprogesterone within 6 months of screening

          -  Use of medications that interact with contraceptive steroid hormones: anti-epileptic
             medications, rifampin, rifabutin, fosamprenavir, etc

          -  Medical condition with safety deemed to be category 3 or 4 when using a combined
             hormonal contraceptive, as determined by the Center for Disease Control Medical
             Eligibility Criteria: current or past history of breast cancer, severe decompensated
             cirrhosis, history of deep vein thrombosis or pulmonary embolus, diabetes with
             nephropathy/retinopathy/neuropathy or other vascular disease diagnosed more than 20
             years ago, current symptomatic gallbladder disease, hypertension, ischemic heart
             disease, known thrombogenic mutations, hepatocellular adenoma, malignant hepatoma,
             multiple risk factors for atherosclerotic cardiovascular disease, multiple sclerosis
             with prolonged immobility, history of peripartum cardiomyopathy, cigarette smoking and
             ≥35yo, history of complicated solid organ transplant, history of stroke, history of
             superficial venous thrombosis not associated with catheter, systemic lupus
             erythematosus with positive antiphospholipid antibodies, valvular heart disease
             complicated by pulmonary hypertension or atrial fibrillation or bacterial
             endocarditis, and acute viral hepatitis
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 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