Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)
Condition: Contraception
Intervention: NOMAC-E2; NETA-EE; Placebo; ethinylestradiol (EE); ferrous fumarate
Intervention description: NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol.; NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol.; tablet; EE 10 μg tablet; ferrous fumarate 75 mg tablet
Intervention MeSH terms: Ferrous fumarate; Ethinyl Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3173.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined Oral Contraceptives

Summary:

      The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate +
      17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active
      American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were
      assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol
      (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.

      Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of
      Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio
      was adapted accordingly for participants randomized after the sample size increase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually active woman, at risk for pregnancy and in need of contraception

          -  Not planning to use other contraceptive methods (including barrier methods [e.g.,
             condoms]) than the study drug, during the study

          -  Willing to use a COC for 12 months (13 cycles)

          -  Body mass index (BMI) of ≥18 and <38 kg/m^2

          -  Good physical and mental health

          -  Willing to complete an electronic diary on a daily basis for the duration of the study

        Exclusion Criteria:

          -  Current smoker and age of >35 years

          -  Presence or history of either venous thromboembolic diseases (deep vein thrombosis
             [DVT], pulmonary embolism) or arterial thromboembolic diseases (myocardial infarction,
             stroke)

          -  History of migraine with focal neurological symptoms

          -  Diabetes mellitus with vascular involvement

          -  Less than two weeks of full remobilization from prolonged immobilization, major
             surgery, any surgery to the legs, or major trauma

          -  Severe hypertension

          -  Severe abnormal lipoproteins in the blood

          -  Pancreatic dysfunction

          -  Presence of history of severe liver disease or liver tumors

          -  Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or
             the breasts)

          -  Undiagnosed vaginal bleeding

          -  Known or suspected pregnancy

          -  Current or history of abuse of alcohol or drugs (e.g., laxatives)

          -  Abnormal cervical smear at screening

          -  Prior to start of treatment, spontaneous menstruation has not occurred following a
             delivery or abortion

          -  Breastfeeding or has been breastfeeding within 2 months prior to start of treatment

          -  Use of any investigational drugs and/or participation in any other clinical trial
             within 2 months prior to start of treatment

          -  Use of any of the following medications prior to or during the study may prohibit
             inclusion: sex hormones (other than pre- and post-treatment non-injectable
             contraceptives), injectable hormonal contraception, phenytoin, barbiturates,
             primidone, bosentan, carbamazepine, topiramate, felbamate, rifampicin, ritonavir,
             nevirapine, efavirenz, griseofulvin, herbal remedies containing Hypericum perforatum
             (e.g., St. John's wort)