A Trial to Assess the Pharmacokinetic Profile (e.g., Uptake, Distribution and Excretion of a Substance in the Body) of Nomegestrol Acetate (NOMAC), Estradiol (E2) and Estrone (E1) After Multiple and Single Dose Administration of the Combined Oral Contraception NOMAC-E2 (COMPLETED)(P05822)

Inclusion Criteria: * Fertile female subjects in good physical and mental health and 18 - 50 years of age at screening * Body mass index (BMI) of 17 ≤ BMI ≤ 29 kg/m2 * Able and willing to use non-hormonal contraceptives during the trial from screening up to follow up * With the last menstrual cycle of 28 +/- 7 days * Able and willing to sign the informed consent form * Able to refrain from smoking, grapefruit containing products, and all use of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) during hospitalization and during pharmacokinetic sampling on days 24-30 and days 35-41 Exclusion Criteria: * History of sensitivity/idiosyncrasy to NOMAC-E2 or chemically related compounds or excipients which could be employed within the study or to any other unknown drug used in the past * Use of any drug or substance within one week prior to the first treatment day, except paracetamol * Clinically relevant history or presence of any medical disorder * Clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening (and just prior to dosing) * Known or suspected pregnancy * History of/or current abuse of drugs or alcohol or solvents, or positive drug or alcohol screen at screening and admission, as judged by the investigator * Positive test result on hepatitis B surface antigen, hepatitis C antibody, or HIV 1/2 serology * Participation in an investigational drug study within 90 days prior to treatment day 1 * Donation of blood within 90 days prior to treatment day 1 * Contra-indications of contraceptive steroids (general) * Abnormal cervical smear at screening, or documentation of abnormal smear performed within 12 months before screening * Clinically relevant transvaginal ultrasound pathology or inability to undergo transvaginal ultrasound evaluation * Use of an injectable hormonal method of contraception; within 6 months of an injectable with a 3-month duration, within 4 months of an injectable with a 2-month duration, within 2 months of an injectable with a 1-month duration * Before spontaneous menstruation has occurred following a delivery or abortion * Breastfeeding or within 2 months after stopping breast feeding prior to start of trial medication * Present use or use during two months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing hypericum perforatum (St. John's Wort) * Present use or use within one month prior to screening of any agent that was known to prolong the QT/QTc interval * History of /or current risk factors for TdP (e.g. heart failure, hypokaliemia, hypomagnesaemia, hypocalcaemia, family history of long QT syndrome, loss of consciousness)