Official Title: “An Open-Label, Randomized, Single Center Trial in Healthy Young Women, to Evaluate the Effects of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg NOMAC and 1.5 mg E2 on Bone Mineral Density (BMD) Compared to a Monophasic COC Containing 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: NOMAC-E2
  • Estradiol and Nomegestrol Acetate Tablets, 2.5 mg NOMAC and 1.5 mg E2
• Drug: LNG/EE
  • Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Estradiol and Nomegestrol Acetate
• Active Comparator: 2
  • Levonorgestrel and Ethinyl Estradiol

Primary Measures

• Bone Mineral Density (BMD) of the lumbar spine (L2-L4) and femoral neck. BMD will be measured by DEXA scans. In addition to the BMD value (g/cm2), the "z-score" will also be determined.
  • Time Frame: 2 years (26 cycles)
    Safety Issue?: No

Secondary Measures

• Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test).
  • Time Frame: 2 years (26 cycles)
    Safety Issue?: No
• Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters.
  • Time Frame: 2 years (26 cycles)
    Safety Issue?: Yes
• Cycle control as determined by patient diary records.
  • Time Frame: 2 years (26 cycles)
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Organon

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00511342

Study ID Number: Protocol No. 292005

ClinicalTrials.gov Identifier: NCT00511342

Health Authority: Norway: Norwegian Medicines Agency