Endometrial Safety Study

December 10, 2014 updated by: Bayer

A Double-blind, Randomized, Multi-center Study to Investigate the Endometrial Safety of a Continuous, Combined, Oral Estrogen/Progestin Preparation (17b-estradiol [E2] / Drospirenone [DRSP]) and to Compare the Bleeding Pattern of Subjects Treated With E2 / DRSP With the Bleeding Pattern of Subjects Treated With E2 / Norethisterone Acetate (NETA) When Used for Hormone Therapy (HT) for 1 Year in Post-menopausal Women

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

662

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

  • Argentina
    • Buenos Aires
      • Lanus Oeste, Buenos Aires, Argentina, 1824
      • San Isidro, Buenos Aires, Argentina, B1642CLN
    • Ciudad Auton. de Buenos Aires
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1280AEB
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1117ABH
  • Austria
      • Innsbruck, Austria, 6020
      • Klagenfurt, Austria, 9020
      • Mürzzuschlag, Austria, 8680
      • St. Poelten, Austria, 3100
      • Wien, Austria, 1030
      • Wien, Austria, 1090
      • Wien, Austria, 1060
      • Wien, Austria, 1200
      • Zeltweg, Austria, 8740
    • Niederösterreich
      • Mödling, Niederösterreich, Austria, 2340
      • Wiener Neustadt, Niederösterreich, Austria, 2700
    • Steiermark
      • Fuerstenfeld, Steiermark, Austria, 8280
    • Tirol
      • Wörgl, Tirol, Austria, 6300
    • Vorarlberg
      • Bregenz, Vorarlberg, Austria, 6900
  • Brazil
      • Sao Paulo, Brazil, 04062-003
    • Goiás
      • Goiania, Goiás, Brazil, 74175-080
    • Parana
      • Curitiba, Parana, Brazil, 80030-220
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
  • Denmark
      • Alborg, Denmark, 9000
      • Ballerup, Denmark, 2750
      • Vejle, Denmark, 7100
  • Italy
      • Bologna, Italy, 40138
      • Cagliari, Italy, 09124
      • Modena, Italy, 41124
      • Novara, Italy, 28100
      • Parma, Italy, 43100
      • Pisa, Italy, 56126
      • Sassari, Italy, 07100
      • Siena, Italy, 53100
  • Mexico
      • Mexico, Mexico, 06700
      • Monterrey, Mexico, 64460
      • México, D.F., Mexico, 14050
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
  • Russian Federation
      • Moscow, Russian Federation, 177997
      • Moscow, Russian Federation, 117415
      • Moskva, Russian Federation, 101000
      • Moskva, Russian Federation, 113093
      • Moskva, Russian Federation, 117997
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
    • California
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92108
    • Colorado
      • Denver, Colorado, United States, 80218
      • Greenwood Village, Colorado, United States, 80111
    • Florida
      • Boynton Beach, Florida, United States, 33437
      • Clearwater, Florida, United States, 33759
    • Idaho
      • Boise, Idaho, United States, 83704
    • Louisiana
      • Amite, Louisiana, United States, 70422
      • Marrero, Louisiana, United States, 70072
    • Nevada
      • Las Vegas, Nevada, United States, 89122
    • Ohio
      • Cleveland, Ohio, United States, 44122
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
    • South Carolina
      • Columbia, South Carolina, United States, 29201
    • Texas
      • Corpus Christi, Texas, United States, 78414
    • Virginia
      • Richmond, Virginia, United States, 23294
    • Washington
      • Seattle, Washington, United States, 98105

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)
  • Non-hysterectomized women.

Exclusion Criteria:

  • Usual exclusion criteria for hormone therapy apply.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
Active Comparator: 0.5mg NETA / 1.0mg E2 (Activella)
One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
Drug: 0.5mg NETA / 1.0mg E2 (Activella)
One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)
Time Frame: Up to one year
The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.
Up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Amenorrhea During Month 1 to 3 of Treatment
Time Frame: Month 1 to Month 3
The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.
Month 1 to Month 3
Number of Participants With Amenorrhea During Month 10 to 12 of Treatment
Time Frame: Month 10 to Month 12
The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.
Month 10 to Month 12

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

University of California, San Francisco
Laboratorium für Klinische Forschung
Diagnostic Cytology Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

August 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 91508
  • 2006-006199-39 (EudraCT Number)
  • 310523 (Other Identifier: Company internal)

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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