To demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone

Condition	Intervention	Phase
Postmenopause	Drug: continuous combined 1 mg estradiol and 5 mg dydrogesterone	Phase III

Ages Eligible for Study:  45 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• Amenorrhoea for >= 12 months.
• Serum estradiol and FSH level within the postmenopausal range
• Baseline endometrial biopsy assessed by light microscopic histological evaluation revealing: insufficient endometrial tissue for diagnosis because of insufficient available (atrophic) endometrial tissue (not because of an inaccessible cervix) and endometrial thickness < 5 mm (double layer) by transvaginal ultrasound, atrophic endometrium, secretory endometrium, menstrual type endometrium, proliferative endometrium

Exclusion Criteria:

• Previous systemic unopposed estrogen replacement therapy over 6 months or more.
• Any estrogen, progestogen, and/or androgen therapy in the last four weeks before Screening Visit (Visit 1). The baseline endometral biopsy should in all cases be taken after cessation of the withdrawal bleeding due to previous hormone replacement therapy.
• History or presence of an estrogen dependent neoplasia (including breast- cancer).
• History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin.

Please refer to this study by ClinicalTrials.gov identifier  NCT00160316

Gregor Eibes       gregor.eibes@solvay.com

Croatia
      Site 10, Zagreb,  Croatia; Recruiting
      Site 11, Zagreb,  Croatia; Recruiting
      Site 12, Zagreb,  Croatia; Recruiting
      Site 13, Zagreb,  Croatia; Recruiting
Poland
      Site 30, Kraków,  Poland; Recruiting
      Site 31, Miechów,  Poland; Recruiting
      Site 32, Katowice,  Poland; Recruiting
      Site 33, Warszawa,  Poland; Recruiting
      Site 34, Lublin,  Poland; Recruiting
      Site 35, Kraków,  Poland; Recruiting
      Site 36, Kraków,  Poland; Recruiting
Romania
      Site 40, Bucharest,  Romania; Recruiting
      Site 41, Bucharest,  Romania; Recruiting
      Site 42, Bucharest,  Romania; Recruiting
      Site 43, Bucharest,  Romania; Recruiting
      Site 44, Bucharest,  Romania; Recruiting
      Site 45, Bucharest,  Romania; Recruiting
Ukraine
      Site 20, Kiev,  Ukraine; Recruiting
      Site 21, Kiev,  Ukraine; Recruiting
      Site 22, Kiev,  Ukraine; Recruiting
      Site 23, Zhaporozh''''e,  Ukraine; Recruiting
      Site 24, Donetsk,  Ukraine; Recruiting

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

Study ID Numbers:  S102.3.117; 2004-000227-15
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00160316
Health Authority: Romania: State Institute for Drug Control
ClinicalTrials.gov processed this record on 2005-09-13