Official Title: “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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: continuous combined estradiol and dydrogesterone
  • 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
• Drug: continuous combined estradiol and dydrogesterone
  • 1 Mg Estradiol and 5 Mg Dydrogesterone
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B
• Placebo Comparator: C

Primary Measures

• The change in the number of moderate to severe hot flushes from baseline to week 13
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8;
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change in the Menopause Rating Scale from baseline to weeks 4 and 13;
  • Time Frame: 52 weeks
    Safety Issue?: No
• 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?: No
• Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;
  • Time Frame: 52 weeks
    Safety Issue?: No
• QualiPause Inventory 7D: weighted sum score of the symptoms
  • Time Frame: 52 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 65 Years

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 August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00251082

Study ID Number: S102.3.119

ClinicalTrials.gov Identifier: NCT00251082

Health Authority: Romania: State Institute for Drug Control