Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis

Inclusion criteria

• Subjects who are able to use the German language, spoken and written
• Postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start
• Availability of a normal mammogram within 1 year prior to trial start
• Good general health
• No significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician

Exclusion criteria

• Known or suspected allergy to estradiol or related products
• Known, suspected or past history of breast cancer
• Abnormal genital bleeding
• Previous oestrogen and/or progestin hormone replacement therapy
• Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
• Hot flushes which require systemic hormone replacement treatment
• Known insulin dependent or non-insulin dependent diabetes mellitus
• Systolic blood pressure (BP) of more than 160 mm Hg and/or diastolic BP or more than 100 mm Hg, currently treated or untreated
• Active deep venous thrombosis or thromboembolic disorders or a history of these conditions
• Active arterial thrombosis or a documented history of this condition
• Known or suspected liver and/or kidney impairment based on medical history, physical examination, and/or laboratory results
• Known HIV infection based on laboratory result
• Porphyria
• Body Mass Index (BMI) above 30.0 kg/m2
• Cervical smear presenting PAP of more than class II
• Known or suspected vaginal infection requiring further treatment
• Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
• Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine
• Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration