Clinical trial NCT00511355 (phase 3, status: completed)
Conditions: contraception
ICD codes: Z92.0, Z30.012, Z30.09
Drugs: nomac-e2, levonorgestrel and ethinyl estradiol
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(C)=O)[C@@]1(C)CC[C@]1([H])[C@@]3([H])CCC(=O)C=C3C(C)=C[C@@]21[H], [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:

          -  Sexually active women, at risk for pregnancy and not planning to use during trial
             medication use;

          -  Women in need for contraception and willing to use an oral contraceptive (OC) for 6
             months (6 cycles);

          -  At least 18 but not older than 50 years of age at the time of screening;

          -  Body mass index = 17 and = 29 kg/m^2;

          -  Good physical and mental health;

          -  Willing to give informed consent in writing

        Exclusion Criteria:

          -  Present use or use within 2 months prior to screening of any other hormonal treatment
             including sex hormones (other than contraceptives), insulin, thyroid and
             corticosteroid hormones (with the exception for local dermatological use);

          -  Contraindications for contraceptive steroids

          -  Presence or history (within 1 year before screening) of alcohol or drug abuse as
             judged by the (sub)investigator.

          -  An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN],
             SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an
             abnormal smear performed within 6 months before screening;

          -  Clinically relevant abnormal laboratory result at screening as judged by the (sub)
             investigator;

          -  Use of an injectable hormonal method of contraception prior to screening; within 6
             months of an injection with a 3 -month duration, within 4 months to screening 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,
             lipid-lowering drugs, anticoagulants and herbal remedies containing Hypericum
             perforatum (St John's Wort);

          -  Use of pharmacological agents which affect the hemostatic system during the
             pretreatment blood sampling: vitamin K (only prohibited within two weeks prior to
             sampling), nonsteroidal anti-inflammatory drugs (NSAIDS) and aspirin (both only
             prohibited during the week prior to sampling);

          -  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.