Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)
Condition: Contraception
Intervention: NOMAC-E2; LNG-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 26 consecutive 28-day menstrual cycles (2 years).; Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Female
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral
      contraceptive (COC) on bone mineral density (BMD).
    

Eligibility criteria:

        Inclusion criteria:

          -  Sexually active women, at risk for pregnancy and not planning to use condoms

        during treatment;

          -  At least 20 but not older than 35 years of age at the time of screening;

          -  BMI = 17 and = 35;

          -  Good physical and mental health;

          -  Willing to give informed consent in writing;

          -  Willing to take part in the trial for two years.

        Exclusion criteria:

          -  Family history of osteoporotic fracture below the age of 70;

          -  Postgastrectomy;

          -  History of eating disorder, viz. anorexia nervosa, bulimia;

          -  Endocrine disorder (including controlled diabetes, [para]thyroid disease, Cushing's
             disease);

          -  Rheumatoid arthritis;

          -  Significant scoliosis;

          -  Fasting parathyroid hormone (PTH) outside the reference range at screening;

          -  Fasting calcitonin outside the reference range at screening;

          -  Prolactin above the reference range (hyperprolactinemia) at screening;

          -  Fasting cholesterol and/or triglycerides above the reference range for age at
             screening (treatment with lipid lowering drugs not allowed);

          -  Engaging in vigorous exercise such as marathon, competitive swimming, triathlon;

          -  Smoking more than ten cigarettes/day;

          -  Use of more than two units of alcohol a day;

          -  Use of one or more of the following drugs:

               -  gonadotropin releasing hormone (GnRH) analogues (also past use for more than six
                  months at any time, or for any period of time less than six months ago is a
                  contraindication);

               -  systemic or inhaled administration of corticosteroids (also past use for more
                  than one year, less than five years ago or any period of time in the past year is
                  a contraindication);

               -  thiazide diuretics;

               -  thyroid hormone;

               -  bisphosphonates;

               -  calcium supplementation in combination with vitamin D supplementation/

        calcitonin;

          -  ever treatment after childhood with fluorides;

               -  Contraindications for contraceptive steroids

               -  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;

               -  Within 12 months after a pregnancy prior to the start of trial medication;

               -  Breastfeeding or within 12 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 post-treatment
                  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.