Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Commercial NOMAC-E2 · 1 trial · 1 indication
Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. Blood samples for pharmacokinetic (PK) evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1.
Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels.
Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. AUClast is the AUC from time 0 to the time of the final quantifiable sample. AUC infinity is the AUC from time 0 to infinity. Blood samples for PK evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1.
Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. AUC72 is the AUC from time 0 to 72 hours. Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels.
| Arm | Type | Description |
|---|---|---|
| Commercial NOMAC-E2, Part 1 | EXPERIMENTAL | 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". |
| Phase 3 NOMAC-E2, Part 1 | ACTIVE_COMPARATOR | 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". |
| Commercial NOMAC-E2, Part 2 | EXPERIMENTAL | 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". |
| Phase 3 NOMAC-E2, Part 2 | ACTIVE_COMPARATOR | 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". |
| Name | Type | Description |
|---|---|---|
| Commercial NOMAC-E2 | DRUG | 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 |
| Phase 3 NOMAC-E2 "Batch A" | DRUG | 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 |
| Phase 3 NOMAC-E2 "Batch B" | DRUG | 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 |
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 surgica...
Commercial NOMAC-E2 is an investigational small molecule being studied in healthy postmenopausal females. It is a combination of nomegestrol acetate (NOMAC) and estradiol (E2) formulated as tablets. The drug is currently in Phase 1 clinical development.
Commercial NOMAC-E2 is being developed by Organon & Co., a company traded on the New York Stock Exchange under the ticker OGN. The drug is currently in Phase 1 clinical development for use in healthy postmenopausal females.
Commercial NOMAC-E2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed for this drug.
Commercial NOMAC-E2 has one completed Phase 1 clinical trial, identified as NCT01345786. This trial was a bioequivalence study comparing commercial versus Phase 3 pivotal clinical batches of NOMAC-E2 tablets. The study enrolled 158 healthy postmenopausal females aged 45 years and older.
Commercial NOMAC-E2 is a formulation of NOMAC-E2, which combines nomegestrol acetate (NOMAC) and estradiol (E2). The commercial batch was studied in a bioequivalence trial against the Phase 3 pivotal clinical batch of NOMAC-E2 tablets.