Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.

• 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; Norethindrone; Norethindrone Acetate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal defined as at least 12 months spontaneous amenorrhoea, with serum FSH (follicle stimulating hormone) levels at least 40 IU/L and estradiol maximum 25 pg/mL. If the date of spontaneous amenorrhoea can not be identified because of previous hormone replacement therapy, serum FSH at least 40 IU/L and estradiol maximum 25 pg/mL

• Non-smoking

• Body Mass Index (BMI) maximum 35.0 kg/m^2

• Able to understand, read and speak German fluently

• Good state of health evidenced by medical history, physical examination including gynecological examination, and results from laboratory examination

• Willing to abstain from intake of caffeine containing food and beverages within 48 hours before drug administration

Exclusion Criteria:

• Known or suspected allergy to trial products or related products

• Previous use of oral, transdermal, nasal spray, vaginal preparations and implants within 8 weeks prior to the planned first drug administration

• Known, suspected or history of breast cancer

• Known or suspected estrogen dependent neoplasia e.g. endometrial cancer

• Abnormal genital bleeding of unknown aetiology

• Known insulin dependent as well as non-insulin dependent diabetes mellitus

• Positive test for HIV (human immunodeficiency virus) and/or hepatitis B and C

• Systolic blood pressure (BP) above or equal to 160 mm Hg and/or diastolic BP above or equal to 100 mm Hg, currently treated or untreated