Clinical trial: Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733) (NCT01490190)

Eligibility criteria:
Inclusion Criteria:

          -  Women at risk of pregnancy and seeking contraception

        Exclusion Criteria:

        Exclusion criteria based on approved prescribing information in India:

          -  Presence or history of venous thrombosis, with or without pulmonary embolism.

          -  Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial
             infarction) or prodromi of a thrombosis (e.g. angina pectoris or

        transient ischemic attack).

          -  Known predisposition for venous or arterial thrombosis, with or without hereditary
             involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency,
             protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid
             antibodies (anticardiolipin antibodies, lupus anticoagulant).

          -  History of migraine with focal neurological symptoms.

          -  Diabetes mellitus with vascular involvement.

          -  The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
             (at the discretion of the doctors)

          -  Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.

          -  Presence or history of severe hepatic disease as long as liver function values have
             not returned to normal.

          -  Presence or history of liver tumors (benign or malignant).

          -  Known or suspected malignant conditions of the genital organs or the breasts, if sex
             steroid-influenced.

          -  Undiagnosed vaginal bleeding.

          -  Known or suspected pregnancy.

          -  Hypersensitivity to the active substances or to any of the excipients of NuvaRing.

          -  Women who are breast feeding
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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