Clinical trial NCT02957630 (phase 1/phase 2, status: completed)
Conditions: contraception, liver metabolism, hemostasis parameter
ICD codes: Z92.0, Z30.012, Z30.09
Drugs: 15 mg e4/3 mg drsp, 30 mcg ee/150 mcg lng, 20 mcg ee/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, [H][C@@]12CC[C@@](O)(C#C)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3, [H][C@@]12CC[C@@](O)(C#C)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3
Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult woman

          -  Negative pregnancy test at subject screening and randomization

          -  Aged 18-50 years (inclusive) at the time of signing the ICF

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

          -  BMI from 18.0 to 30.0 kg/m², inclusive, at time of screening visit

          -  Able to fulfil the requirements of the protocol and have indicated a willingness to
             participate in the study by providing written informed consent

        Exclusion Criteria:

          -  Known hypersensitivity to any of the investigational product ingredients

          -  Smoking if > 35 years old

          -  Dyslipoproteinemia or use of antilipidemic agent

          -  Known diabetes mellitus

          -  Current use of antidiabetic drugs, including insulin

          -  Arterial hypertension

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

          -  Any condition associated with abnormal uterine/vaginal bleeding.

          -  Presence of an undiagnosed breast mass

          -  Current symptomatic gallbladder disease

          -  History of pregnancy- or COC-related cholestasis

          -  Presence or history of severe hepatic disease

          -  Presence or history of pancreatitis if associated with hypertriglyceridemia

          -  Porphyria

          -  Presence or history of benign liver tumors (focal nodular hyperplasia and
             hepatocellular adenoma)

          -  Presence of renal impairment (glomerular filtration rate [GFR] <60 mL/min/1.73m²)

          -  Hyperkalemia or presence of conditions that predispose to hyperkalemia

          -  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 within 12 months prior to screening

          -  Presence or history of 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
             randomization. Subjects who participated in an oral contraceptive clinical study using
             Food and Drug Administration (FDA)/European Union (EU) approved active ingredients,
             may be randomized 2 months (60 days) after completing the preceding study

          -  Sponsor, contract research organization (CRO) or Principal Investigator's (PI's) site
             personnel directly affiliated with this study

          -  Is judged by the PI to be unsuitable for any reason