Pharmacology, Clinical Clinical Trial
Official title:
Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 2 mg Estradiol Valerate and 3 mg Dienogest Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women
| Verified date | July 2016 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | January 2010 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 45 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | t½ | 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 | No |
| Secondary | ?z | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
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