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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011963-35 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol + dienogest + levomefolate | Experimental | Treatment A |
|
| Estradiol + dienogest | Active Comparator | Treatment B |
|
| Levomefolate | Active Comparator | Treatment C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the concentration vs time curve from zero to infinity for DNG | 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 |
| Cmax | Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected) | 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(0-tlast) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| tmax | Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected) | 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 |
| t½ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neu-Ulm | Bavaria | 89231 | Germany |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| 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 |
|
Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF
| 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 |
| λz | Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF | 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(0-tlast) | AUC from time 0 to the last data point above the lower limit of quantitation for DNG | 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 | Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected) | 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 |
| ID | Term |
|---|---|
| C023635 | dienogest |
| C569381 | levomefolate calcium |
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