Official Title: “Endometrial Safety of a Low Dose Continuous Combined 17 -Estradiol/Dydrogesterone Hormone Replacement Regimen (E2 0.5 mg/ D 2.5 mg) in Postmenopausal Women - A One-Year, Open Label, Multi-Center Study”

The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
  • p.o. daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period
  • Time Frame: 52 weeks
    Safety Issue?: Yes

Secondary Measures

• Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);
  • Time Frame: 52 weeks
    Safety Issue?: Yes
• Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;
  • Time Frame: 52 weeks
    Safety Issue?: Yes
• QualiPause Inventory (domains: psychological, vasomotor, somatic, sexual, menstrual, androgenic): average score of the single items within the domain; QualiPause Inventory 7D: weighted sum score of the symptoms
  • Time Frame: 52 weeks
    Safety Issue?: No

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 endometrial 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160316

Study ID Number: S102.3.117

ClinicalTrials.gov Identifier: NCT00160316

Health Authority: Romania: State Institute for Drug Control