Phase 1
Completed N=158
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)
Healthy Postmenopausal Females
Source: ClinicalTrials.gov NCT01345786 ↗
Enrolled (actual)
158
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC) — 6.22; 4.51; 8.03; 7.20 ng/mL
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").
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC) |
6.22; 4.51; 8.03; 7.20 | — |
| PRIMARY Baseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2) |
56.1; 45.1; 44.4; 41.5 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measurable Sample (AUC Last) and Area Under the Concentration-time Curve From Time 0 to Infinity (AUC Infinity) for NOMAC |
87.3; 78.1; 109; 106; 102; 93.3 | — |
| PRIMARY Baseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2 |
1315; 1278; 1359; 1342 | — |
| SECONDARY Tmax of NOMAC |
2; 2; 2; 2 | — |
| SECONDARY Tmax of E2 |
6.02; 8; 8; 8 | — |
| SECONDARY Terminal Phase Half Life (t1/2) of NOMAC |
58.5; 61; 70.8; 69.9 | — |
| SECONDARY t1/2 of E2 |
39.9; 39.1; 33.1; 34.6 | — |
| SECONDARY Clearance (Calculated for NOMAC Only) |
28.3; 29.9; 21.1; 22.1 | — |
| SECONDARY Volume of Distribution (Calculated for NOMAC Only) |
2208; 2445; 1988; 2061 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01345786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.