Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)

A 2-part, Cross-over Trial of NOMAC-E2 to Assess Bioequivalence Between the Phase 3 Pivotal Clinical Batches and a Batch Prepared Using the Commercial Drug Manufacturing Process

For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized, single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at two sites, one site per study part. The primary objective of Part 1 was to assess the bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch A"). The primary objective of Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch B").

Key Inclusion Criteria:

• Healthy postmenopausal females between the ages of 45 and 70 years, inclusive, having a Body Mass Index (BMI) between 18 and 32, inclusive;
• Free of any clinically significant disease that would interfere with the study evaluations.

Key Exclusion Criteria:

• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug;
• History of any infectious disease that affected the subject's ability to participate in the trial;
• History of alcohol or drug abuse in the past 2 years;
• Previously received NOMAC-E2;
• Current participation in another clinical study or had participated in a clinical study (eg, laboratory or clinical evaluation) within 30 days of baseline;
• Smoked more than 10 cigarettes or equivalent tobacco use per day;
• History of malignancy;
• Contraindications for the use of contraceptive steroids;
• Recent history of medication use of certain medications specified in the protocol.