• Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test). [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
• Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: Yes ]
• Cycle control as determined by patient [electronic] diaries. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
• Acceptability will be evaluated on the basis of discontinuation rates and reasons for discontinuation. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]

• Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test). [ Time Frame: One year (13 cycles) ]
• Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters. [ Time Frame: One year (13 cycles) ]
• Cycle control as determined by patient [electronic] diaries. [ Time Frame: One year (13 cycles) ]
• Acceptability will be evaluated on the basis of discontinuation rates and reasons for discontinuation. [ Time Frame: One year (13 cycles) ]

• User satisfaction will be evaluated using "Patient Reported Outcome Questionnaires" (self-administered). [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
• Acne will be assessed by regular skin examinations. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]

• User satisfaction will be evaluated using "Patient Reported Outcome Questionnaires" (self-administered). [ Time Frame: One year (13 cycles) ]
• Acne will be assessed by regular skin examinations. [ Time Frame: One year (13 cycles) ]

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the NOMAC-E2 COC in a large group of women aged 18-50 years.

• Drug: NOMAC E2
• Drug: drospirenone and ethinyl estradiol tablets

• Active Comparator: nomegestrol acetate (NOMAC) and estradiol (E2)
• Active Comparator: drospirenone and ethinyl estradiol tablets

Inclusion Criteria:

• Sexually active women, at risk for pregnancy and not planning to use condoms;
• Women in need for contraception and willing to use an OC for 12 months (13 cycles);
• At least 18 but not older than 50 years of age at the time of screening;
• Body mass index >=17 and <=35;
• Good physical and mental health;
• Willing to give informed consent in writing.

Exclusion Criteria:

• Contraindications for contraceptive steroids
• In accordance with the SmPC/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
• Renal insufficiency;
• Hepatic dysfunction;
• Adrenal insufficiency.
• An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], SIL, carcinoma in situ, invasive carcinoma) at screening;
• Clinically relevant abnormal laboratory result at screening as judged by the investigator;
• Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
• Before spontaneous menstruation has occurred following a delivery or abortion;
• Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
• Present use or use within 2 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 posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
• Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
• Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).