E4/DRSP Ovarian Function Inhibition Study

Inclusion criteria

• Overtly healthy female subjects, as determined by medical history, physical examination including breast examination, gynecological examination (including cervical smear [Pap smear]), vital signs, ECG, echocardiogram, and laboratory tests.
• Negative pregnancy test at subject screening.
• Women who ovulate in the Pre-Treatment Cycle.
• Willing to use a non-hormonal method of contraception (e.g. condom) during the wash-out period, Pre-Treatment Cycle and Post-Treatment Cycle.
• BMI between 18.0 and 35.0 kg/m², inclusive, at time of Screening.
• Able to fulfill the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent form (ICF).

Exclusion criteria

• Irregular menstrual cycle.
• Amenorrhea or abnormal uterine bleeding.
• Clinically relevant abnormal laboratory result at Screening.
• Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound.
• Known hypersensitivity to any of the investigational or reference product ingredients.
• Intention to become pregnant during the course of the study.
• Pregnancy during accurate hormonal contraceptive use in the past.
• 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.
• Any arterial hypertension.
• Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.
• Complicated valvular heart disease.
• History of pregnancy-related cardiomyopathy or moderately or severely impaired cardiac function.
• Systemic lupus erythematosus.
• Presence or history of migraine with aura.
• Abnormal Papanicolaou (PAP) smear result.
• 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.
• Any prior procedure, disease or condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational product.
• Uncontrolled thyroid disorders.
• Have received an investigational drug within the last 2 cycles prior to start of Pre-Treatment Cycle. Subjects who participated in an oral contraceptive clinical study, using Food and Drug Administration (FDA)/European Union (EU) approved active ingredients, may start the Pre-Treatment Cycle one cycle after last medication intake of the preceding study.
• Sponsor, contract research organization (CRO) or PI's site personnel directly affiliated with this study.
• Is judged by the PI to be unsuitable for any reason.