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

Organon

Status and phase: Completed; Phase 1

Conditions: Healthy Postmenopausal Females

Treatments: Drug: Commercial NOMAC-E2; Drug: Phase 3 NOMAC-E2 "Batch A"; Drug: Phase 3 NOMAC-E2 "Batch B"

Study type: Interventional

Funder types: Industry

Identifiers

NCT01345786

P06328

Details and patient eligibility

About

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").

Enrollment: 158 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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158 participants in 4 patient groups

Commercial NOMAC-E2, Part 1

Experimental group

Description:

Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from "Site 1".

Treatment:

Drug: Commercial NOMAC-E2

Phase 3 NOMAC-E2, Part 1

Active Comparator group

Description:

Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program ("Batch A"), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from "Site 1".

Treatment:

Drug: Phase 3 NOMAC-E2 "Batch A"

Commercial NOMAC-E2, Part 2

Experimental group

Description:

Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from "Site 2".

Treatment:

Drug: Commercial NOMAC-E2

Phase 3 NOMAC-E2, Part 2

Active Comparator group

Description:

Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program ("Batch B"), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from "Site 2".

Treatment:

Drug: Phase 3 NOMAC-E2 "Batch B"