Trial Condition(s):

Postmenopause

Endometrial safety study

Bayer Identifier:

91508

ClinicalTrials.gov Identifier:

NCT00522873

EudraCT Number:

2006-006199-39

EU CT Number:

Not Available

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
662
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Low-Dose E2/DRSP (BAY86-4891)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Dr. Guenther Heytmanek

Wien, Austria, 1030

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Praxis Dr. Wollein

Mödling, Austria, 2340

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Praxis Dr. Norman Ruth

Wörgl, Austria, 6300

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Dr. Sigrid Schmidl-Amann

St. Poelten, Austria, 3100

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Dr. Walter Paulik

Zeltweg, Austria, 8740

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Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

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Praxis Fr. Dr. Barbara Eberz

Mürzzuschlag, Austria, 8680

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Center for Clinical& Basic Research

Alborg, Denmark, 9000

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Center for Clinical & Basic Research

Vejle, Denmark, 7100

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A.O.U. Senese

Siena, Italy, 53100

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A.O.U. di Bologna

Bologna, Italy, 40138

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A.O.U. di Parma

Parma, Italy, 43100

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Scientific Research Center of Obst., Gyn. and Perinatology

Moskva, Russia, 117997

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Scientific Research Center of Obst., Gyn. and Perinatology

Moscow, Russia, 177997

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Municipal Hospital N 4

Moskva, Russia, 113093

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Moscow Regional Research Institue of Obstetrics & Gynecology

Moskva, Russia, 101000

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Praxis Dr. Langer

Fuerstenfeld, Austria, 8280

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Dr. Max Stiglbauer

Wiener Neustadt, Austria, 2700

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Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

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Dr. Wolfgang Bartl

Wien, Austria, 1200

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Dr. Ewald Boschitsch

Wien, Austria, 1060

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Dr. Bernhard Svejda

Klagenfurt, Austria, 9020

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Landeskrankenhaus Bregenz

Bregenz, Austria, 6900

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Center for Clinical & Basic Research

Ballerup, Denmark, 2750

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A.O.U. Pisana

Pisa, Italy, 56126

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A.O.U. di Cagliari

Cagliari, Italy, 09124

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A.O.U. di Sassari

Sassari, Italy, 07100

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A.O.U. di Modena Policlinico

Modena, Italy, 41124

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A.O.U. Maggiore della Carità

Novara, Italy, 28100

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31 State Hospital

Moscow, Russia, 117415

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Instituto Médico de Asistencia e Investigación

Buenos Aires, Argentina, C1117ABH

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Instituto Ginecologico Buenos Aires

Lanus Oeste, Argentina, 1824

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Clinica de la Mujer San Isidro Labrador - Ginec

San Isidro, Argentina, B1642CLN

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Hospital Británico

Buenos Aires, Argentina, C1280AEB

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Clinica de la Mujer San Isidro Labrador - Ginec

San Isidro, Argentina, B1642CLN

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Hospital Moinhos de Vento-Centro Clínico

Porto Alegre, Brazil, 90035-001

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Instituto de Saude e Bem Estar Mulher

Sao Paulo, Brazil, 04062-003

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Fundación Médica Sur CIF BIOTEC

México, D.F., Mexico, 14050

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Rapid Medical Research Inc.

Cleveland, United States, 44122

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Clinical Trial Center of Colorado

Greenwood Village, United States, 80111

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Medical Center for Clinical Research

San Diego, United States, 92108

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York Clinical Consulting

Marrero, United States, 70072

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Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

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Women's Medical Research Group, LLC

Clearwater, United States, 33759

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Advanced Research Associates

Corpus Christi, United States, 78414

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Centro Tiempo

Buenos Aires, Argentina, C1117ABH

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Centro de Estudos e Pesquisas em Reproducao Humana e Fertil.

Curitiba, Brazil, 80030-220

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MAA Centro de Pesquisa Clinica

Goiania, Brazil, 74175-080

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Instituto Nacional de Perinatología

Mexico, Mexico

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Hospital María José

Mexico, Mexico, 06700

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Hospital Universitario "José Eleuterio González"

Monterrey, Mexico, 64460

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Visions Clinical Research

Boynton Beach, United States, 33437

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Genesis Center for Clinical Research

San Diego, United States, 92103

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National Clinical Research, Inc.

Richmond, United States, 23294

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Dr. Yekaterina Khronusova, MD

Las Vegas, United States, 89122

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Women's Clinical Research Center DBA Seattle Women's Health

Seattle, United States, 98105

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South Carolina Clinical Research Center

Columbia, United States, 29201

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York Clinical Consulting

Amite, United States, 70422

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Downtown Women's Healthcare

Denver, United States, 80218

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Advanced Clinical Research

Boise, United States, 83704

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East Valley Family Physicians, PLC

Chandler, United States, 85224

Trial Design