Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis

Inclusion Criteria:

• Subjects who are able to use German language in speaking and writing
• Postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening
• Serum FSH (Follicle Stimulating Hormone) levels above 40 mIU/ml and estradiol below 20 pg/ml
• Maximum 5% superficial cells as assessed by evaluation of vaginal cytology
• Endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable)
• Availability of a normal mammogram within one year prior to trial start
• Good general health as assessed by the Investigator and based on medical history, and physical and laboratory examinations

Exclusion Criteria:

• Known or suspected allergy to trial product or related products
• Known, suspected or past history of breast cancer
• Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer
• Endometrial hyperplasia or endometrial polyps diagnosed during the screening period
• Abnormal genital bleeding of unknown etiology
• Previous estrogen and/ or progestin hormone replacement therapy