Table 2:
Summary of literature on pharmacokinetic studies of micronized vaginal progesterone in non-pregnant women and this study on pregnant women in the second trimester. AUC: area under curve; Cmax: maximum concentration; Tmax: time to maximum concentration. Data presented as mean±SD or median[IQR]. AUC subscript indicates time over which AUC calculated after one dose.
| Study | Study Population | Dose | AUC (ng*h/ml) | Cmax (ng/ml) | Tmax (h) |
|---|---|---|---|---|---|
| Paulson 20148 | Healthy, premenopausal women (N=9) | 200mg micronized vaginal progesterone insert (PVI Ferring Pharmaceutials), rapid disintegrating | 138±35 (0-24) | 11.5±3.9 | 12.0±4.9 |
| Norman 199114 | Healthy, premenopausal women (N=10) | 400mg (Cyclogest suppository, Cox Pharmaceuticals) | 308±208(0-96) | 28±18.7 | 3.1 |
| Erny 198919 | Healthy, premenopausal women (N=6) | 100mg (Utrogestan) | 88.8 [49.12-151.7] (0-24) | 8.5 [5.8-12.6] | 2.8 [2-4] |
| Study Number 00532320 | Healthy post menopausal women (N=18 | 100mg (Utrogestan) | 209.6±113.7^(0-96) | 6.8±1.6^ | 9.0±7.1 |
| Archer 199515 | Healthy post menopausal women (N=10) | 100mg (Zetachron) | 165.6±76.9(0-24) | 14.5±4.6 | 3.2±12 |
| Boelig 2018 | Healthy pregnant singletons 18-23 weeks’ gestation (N=6) | 200mg (Virtus Pharmaceutical) | 112 [−43 to 239]* (0-24) | 11 [2 to 22]* | 12 [4 to 15] |
values are change in serum progesterone from baseline.^Converted from original value using 314.46g/mol