Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
Condition: Contraception
Intervention: NOMAC-E2; DRSP-EE
Intervention description: Nomegestrol Acetate and Estradiol 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 13 consecutive 28-day menstrual cycles (1 year).; Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2152.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility criteria:

        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 oral contraceptive (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 (BMI) of >/= 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 Summary of Product Characteristics (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],

        Squamous Intraepithelial Lesion [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.