E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - US/CA Study

Inclusion Criteria:

- Heterosexually active female at risk for pregnancy and requesting contraception.

- Negative serum pregnancy test at subject screening.

- Willing to use the investigational product as the primary method of contraception for
13 consecutive cycles.

- Good physical and mental health on the basis of medical, surgical and gynecological
history, physical examination, gynecological examination, clinical laboratory, and
vital signs.

- Body mass index (BMI) below or equal to (≤) 35.0 kg/m2.

- Able to fulfill the requirements of the protocol and have indicated a willingness to
participate in the study by providing written IC.

- Willing and able to complete the diaries and questionnaires.

Exclusion Criteria:

- Known hypersensitivity to any of the investigational product ingredients.

- Smoking if ≥ 35 years old, at screening.

- Any condition associated with decrease fertility.

- Dyslipoproteinemia requiring active treatment with antilipidemic agent.

- Diabetes mellitus with vascular involvement (nephropathy, retinopathy, neuropathy,
other) or diabetes mellitus of more than 20-year duration.

- Arterial hypertension.

- Any condition associated with an increased risk of venous thromboembolism and/or
arterial thromboembolism.

- Any condition associated with abnormal uterine/vaginal bleeding.

- Abnormal Pap test based on current international recommendations.

- Presence of an undiagnosed breast mass.

- Current symptomatic gallbladder disease.

- History of COC related cholestasis.

- Presence or history of severe hepatic disease.

- Presence or history of pancreatitis if associated with hypertriglyceridemia.

- Porphyria.

- Presence or history of hepatocellular adenoma or malignant liver tumors.

- Renal impairment.

- Hyperkaliemia or presence of conditions that predispose to hyperkaliemia.

- Presence or history of hormone-related malignancy.

- History of non-hormone-related malignancy within 5 years before screening. Subjects
with a non-melanoma skin cancer are allowed in the study.

- History of alcohol or drug abuse (including laxatives) within 12 months prior to
screening.

- Use of drugs potentially triggering interactions with COCs.

- Any condition that could result in altered absorption, excessive accumulation,
impaired metabolism, or altered excretion of the investigational product.

- Uncontrolled thyroid disorders.

- Participation in another investigational drug clinical study within 1 month (30 days)
or have received an investigational drug within the last 3 months (90 days) prior to
study entry. Subjects who participated in an oral contraceptive clinical study, using
FDA/EU approved active ingredients, may be enrolled 2 months (60 days) after
completing the preceding study.

- Sponsor, CRO or Investigator's site personnel directly affiliated with this study.

- Is judged by the Investigator to be unsuitable for any reason.