Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 98-7079, Estradiolvalerate/ Dienogest/ Levomefolate calcium · 1 trial · 1 indication
Area under the concentration vs time curve from zero to infinity for DNG
Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
AUC from time 0 to the last data point above the lower limit of quantitation for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
| Arm | Type | Description |
|---|---|---|
| Estradiol + dienogest + levomefolate | EXPERIMENTAL | Treatment A |
| Estradiol + dienogest | ACTIVE_COMPARATOR | Treatment B |
| Levomefolate | ACTIVE_COMPARATOR | Treatment C |
| Name | Type | Description |
|---|---|---|
| BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium | DRUG | Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days |
| BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG) | DRUG | Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days |
| BAY 86-7660,levomefolate calcium | DRUG | Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days |
Inclusion Criteria: * Healthy postmenopausal women, age: 45-75 years with body mass index between ≥18 and ≤30 kg/m2. Post-menopausal state revealed by: medical history, and hormone analyses in serum: estradiol ≤20 pg/mL and in women \<60 years old: follicle-stimulating hormone ≥ 40 IU/L at screenin...