Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

March 11, 2008 updated by: Solvay Pharmaceuticals

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

454

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
      • Zagreb, Croatia
        • Site 10
  • Poland
      • Katowice, Poland
        • Site 32
      • Kraków, Poland
        • Site 30
      • Kraków, Poland
        • Site 35
      • Kraków, Poland
        • Site 36
      • Lublin, Poland
        • Site 34
      • Miechów, Poland
        • Site 31
      • Warszawa, Poland
        • Site 33
  • Romania
      • Bucharest, Romania
        • Site 41
      • Bucharest, Romania
        • Site 42
      • Bucharest, Romania
        • Site 44
      • Bucharest, Romania
        • Site 40
      • Bucharest, Romania
        • Site 43
      • Bucharest, Romania
        • Site 45
  • Ukraine
      • Donetsk, Ukraine
        • Site 24
      • Kiev, Ukraine
        • Site 20
      • Kiev, Ukraine
        • Site 21
      • Kiev, Ukraine
        • Site 22
      • Zaporozhye, Ukraine
        • Site 23

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

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
p.o. daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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 (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
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

April 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 12, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S102.3.117
  • 2004-000227-15

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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