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

The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.


Eligibility Criteria:
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 informed consent.
* 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 combined oral contraceptive (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/European (EU) approved active ingredients, may be enrolled 2 months (60 days) after completing the preceding study.
* Sponsor, Contract Research Organization (CRO) or Investigator's site personnel directly affiliated with this study.
* Is judged by the Investigator to be unsuitable for any reason.