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

March 11, 2008 updated by: Solvay Pharmaceuticals

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

391

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia
        • Site 11
      • Zagreb, Croatia
        • Site 12
      • Zagreb, Croatia
        • Site 13
  • France
      • Cannes, France
        • Site 23
      • Cannes, France
        • Site 24
      • Montpellier, France
        • Site 21
      • Montpellier, France
        • Site 22
  • Poland
      • Katowice, Poland
        • Site 34
      • Kraków, Poland
        • Site 33
      • Lódź, Poland
        • Site 32
      • Warszawa, Poland
        • Site 31
  • Romania
      • Bucharest, Romania
        • Site 41
      • Bucharest, Romania
        • Site 42
      • Bucharest, Romania
        • Site 44
      • Craiova, Jud.Dolj, Romania
        • Site 43
  • Russian Federation
      • Moscow, Russian Federation
        • Site 51
      • Moscow, Russian Federation
        • Site 52
      • Moscow, Russian Federation
        • Site 53

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
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
Placebo Comparator: C
Drug: Placebo
Placebo
Experimental: A
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in the number of moderate to severe hot flushes from baseline to week 13
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks
Change in the Menopause Rating Scale from baseline to weeks 4 and 13;
Time Frame: 52 weeks
52 weeks
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
52 weeks
Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;
Time Frame: 52 weeks
52 weeks
QualiPause Inventory 7D: weighted sum score of the symptoms
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 9, 2005

Study Record Updates

Last Update Posted (Estimate)

March 12, 2008

Last Update Submitted That Met QC Criteria

March 11, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S102.3.119
  • 2004-00215-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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