Clinical trial NCT02817841 (phase 3, status: completed)
Conditions: contraception
ICD codes: Z92.0, Z30.012, Z30.09
Drugs: 15 mg e4/3 mg drsp
SMILES: [H][C@@]12C[C@]1([H])[C@@]1([H])[C@]3([H])[C@]4([H])C[C@]4([H])[C@@]4(CCC(=O)O4)[C@@]3(C)CC[C@]1([H])[C@@]1(C)CCC(=O)C=C21
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.