Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 86-7660, 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...
BAY 86-7660, also known as levomefolate calcium, is a small molecule being investigated for pharmacology and clinical applications. It is currently in Phase 1 clinical development. The drug has been studied in a bioequivalence trial involving healthy female volunteers aged 45 years and older.
BAY 86-7660 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical development.
BAY 86-7660 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, and the drug is not currently in any active trials.
BAY 86-7660 has been studied in one completed Phase 1 clinical trial, identified as NCT00941057. This was a bioequivalence study comparing 2 mg estradiol valerate and 3 mg dienogest with and without levomefolate calcium. The trial enrolled 43 healthy female volunteers in Germany.
Yes, BAY 86-7660 is also known as levomefolate calcium. The drug is being developed by Bayer AG and is currently in Phase 1 clinical development for pharmacology and clinical applications.