Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone

To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year

Inclusion Criteria:

• Non-hysterectomised postmenopausal women
• Amenorrhoea for >= 12 months
• Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range

Exclusion Criteria:

• Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication
• Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma).
• Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness >= 5 mm (double layer) by transvaginal ultrasound.
• The presence of an endometrial polyp at baseline.
• Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1).
• Estradiol pellet/implant therapy during the past 6 months.
• Previous systemic unopposed estrogen replacement therapy over 6 months or more.
• History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin