Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)

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.