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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Hormones; Norethindrone; Norethindrone Acetate; Polyestradiol phosphate

Criteria

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