Trial Condition(s):
Pharmacology, clinical
Bioequivalence study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) without and with levomefolate calcium
Bayer Identifier:
13469
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Neu-Ulm, Germany, 89231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- AUCArea under the concentration vs time curve from zero to infinity for DNGTimeframe: 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
- CmaxMaximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)Timeframe: 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)Timeframe: 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
Secondary Outcome
- tmaxTime to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected)Timeframe: 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
- t½Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THFTimeframe: 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
- λzApparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THFTimeframe: 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 DNGTimeframe: 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
- AUCArea under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected)Timeframe: 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
Additional Information
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