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

Bayer

Status and phase

Completed

Phase 1

Conditions

Pharmacology, Clinical

Treatments

Drug: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium

Drug: BAY 86-7660,levomefolate calcium

Drug: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00941057

2009-011963-35 (EudraCT Number)

13469

Details and patient eligibility

About

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

Enrollment

43 patients

Sex

Female

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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