NCT01345786

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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").

Conditions

• Healthy Postmenopausal Females

Interventions

Type	Name	Description
DRUG	Commercial NOMAC-E2	1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination commercial tablet orally in the morning on Day 1 for all periods
DRUG	Phase 3 NOMAC-E2 "Batch A"	1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch A") orally in the morning on Day 1 for all periods
DRUG	Phase 3 NOMAC-E2 "Batch B"	1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch B") orally in the morning on Day 1 for all periods

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2011-05-02
• Last updated: 2022-02-09
• Results posted: 2011-08-29