Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women

Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1.0 mg Estradiol + 0.5 mg Norethisterone Acetate

This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.

Inclusion Criteria:

• Healthy
• Postmenopausal
• Caucasian race
• Smoking (up to 5 cig./per day) is allowed
• Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination

Exclusion Criteria:

• Known or suspected allergy to trial products or related products
• Previous participation in this trial
• Previous estrogen and/or progestin hormone replacement therapy
• Known, suspected or history of breast cancer
• Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated
• Body Mass Index (BMI) above 35.0 kg/m^2