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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Calcium; Calcium, Dietary; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate; Tetrahydrofolates

Criteria

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