Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)
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: 2281.0
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 >=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.

          -  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).