Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)

Inclusion Criteria:

- Sexually active woman, at risk for pregnancy and in need of contraception

- Not planning to use other contraceptive methods (including barrier methods [e.g.,
condoms]) than the study drug, during the study

- Willing to use a COC for 12 months (13 cycles)

- Body mass index (BMI) of ≥ 18 and < 38 kg/m^2

- Good physical and mental health

- Willing to complete an electronic diary on a daily basis for the duration of the
study

Exclusion Criteria:

- Current smoker and age of > 35 years

- Presence or history of either venous thromboembolic diseases (deep vein thrombosis
[DVT], pulmonary embolism) or arterial thromboembolic diseases (myocardial
infarction, stroke)

- History of migraine with focal neurological symptoms

- Diabetes mellitus with vascular involvement

- Less than two weeks of full remobilization from prolonged immobilization, major
surgery, any surgery to the legs, or major trauma

- Severe hypertension

- Severe abnormal lipoproteins in the blood

- Pancreatic dysfunction

- Presence of history of severe liver disease or liver tumors

- Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs
or the breasts)

- Undiagnosed vaginal bleeding

- Known or suspected pregnancy

- Current or history of abuse of alcohol or drugs (e.g., laxatives)

- Abnormal cervical smear at screening

- Before spontaneous menstruation has occurred following a delivery or abortion

- Breastfeeding or has been breastfeeding within 2 months prior to start of treatment

- Use of any investigational drugs and/or participation in any other clinical trial
within 2 months prior to start of treatment

- Use of any of the following prohibited medications within 2 months prior to start of
treatment and/or will need to continue these medications: sex hormones (other than
pre-treatment non-injectable contraceptives), injectable hormonal contraception,
phenytoin, barbiturates, primidone, bosentan, carbamazepine, topiramate, felbamate,
rifampicin, ritonavir, nevirapine, efavirenz, griseofulvin, herbal remedies
containing St. John's wort (Hypericum perforatum)