Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)
Condition: Contraception
Intervention: NOMAC-E2; Levonorgestrel and Ethinyl Estradiol
Intervention description: Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.; Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to evaluate the effects of the combined oral
      contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal
      function, and thyroid function.
    

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.