Pharmacology, Clinical
Conditions
Brief summary
Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium
Interventions
DRUGBAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium
Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
DRUGBAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)
Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days
DRUGBAY 86-7660,levomefolate calcium
Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
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 screening
Exclusion criteria
* Contraindications for use of combined (Estradiolvalerate/Dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease) * Regular intake of medication * Clinically relevant findings (ECG, blood pressure, physical and gynaecological examination, laboratory examination) * Smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C | Area under the concentration vs time curve from zero to infinity for DNG |
| Cmax | Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C | Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected) |
| AUC(0-tlast) | Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0-tlast) | Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C | AUC from time 0 to the last data point above the lower limit of quantitation for DNG |
| tmax | Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C | Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected) |
| AUC | Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C | Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected) |
| t½ | Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C | Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF |
| λz | Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C | Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF |
Countries
Germany
Outcome results
None listed