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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
662

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Postmenopause

Clinical Trials on 0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings