Table 2.
Mean estrogen values in pharmacokinetic trials (geometric mean; baseline adjusted), and ANOVA results for comparisons between test a and reference b products. p Values indicate statistical significance at <0.05 between test and reference products.
|
AUC0-24 (pg·h/ml) |
Cmax (pg/ml) |
tmax (h) |
||||||
|---|---|---|---|---|---|---|---|---|
| Dose (μg) | Test | Reference | p | Test | Reference | p | Test | Reference |
| Estradiol | ||||||||
| 10 | 49.62 | 132.92 | <0.0001 | 14.38 | 20.38 | 0.0194 | 1.75 | 9.28 |
| 25 | 89.21 | 292.1 | <0.0001 | 23.08 | 42.70 | <0.0001 | 1.85 | 11.18 |
| Estrone | ||||||||
| 10 | 24.24 | 48.24 | 0.0002 | 5.15 | 6.98 | 0.0127 | 5.87 | 9.07 |
| 25 | 50.22 | 165.5 | <0.0001 | 10.69 | 23.58 | 0.0002 | 5.14 | 11.48 |
|
Estrone sulfate |
||||||||
| 10 | 66.6 (ng·h/dl) | 121.6 (ng·h/dl) | 0.0091 | 12.2 (ng/dl) | 16.9 (ng/dl) | 0.0366 | 5.5 | 8.8 |
| 25 | 4290 | 7330 | 0.0031 | 497.6 | 730.6 | 0.0042 | 11.75 | 15.87 |
a, Test product: TX-004HR; TherapeuticsMD, Inc., Boca Raton, FL, USA; b, reference product: Vagifem®; Novo Nordisk, Plainsboro, NJ, USA.