Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium

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

Summary

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

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

Details

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

Criteria

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