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

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.
• •Use of drugs potentially triggering interactions with COCs.
• •History of alcohol or drug abuse (including laxatives) within 12 months prior to screening.
• •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.