Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium

Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 3 mg EV Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women

Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium

Inclusion Criteria:

• BMI:>18 <30 kg/m²
• Healthy female volunteers
• Age 45-75 years
• Postmenopausal state

Exclusion Criteria:

• Contraindications for use of combined (Estradiol Valerate/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