Trial Condition(s):

Postmenopause

Endometrial safety study

Bayer Identifier:

91508

ClinicalTrials.gov Identifier:

NCT00522873

EudraCT Number:

2006-006199-39

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
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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
Status
LocationsStatus
Locations

Dr. Guenther Heytmanek

Wien, Austria, 1030

Status
Completed
 
Locations

Praxis Dr. Wollein

Mödling, Austria, 2340

Status
Completed
 
Locations

Praxis Dr. Norman Ruth

Wörgl, Austria, 6300

Status
Completed
 
Locations

Dr. Sigrid Schmidl-Amann

St. Poelten, Austria, 3100

Status
Completed
 
Locations

Dr. Walter Paulik

Zeltweg, Austria, 8740

Status
Terminated
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Praxis Fr. Dr. Barbara Eberz

Mürzzuschlag, Austria, 8680

Status
Completed
 
Locations

Center for Clinical& Basic Research

Alborg, Denmark, 9000

Status
Completed
 
Locations

Center for Clinical & Basic Research

Vejle, Denmark, 7100

Status
Completed
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

A.O.U. di Bologna

Bologna, Italy, 40138

Status
Completed
 
Locations

A.O.U. di Parma

Parma, Italy, 43100

Status
Completed
 
Locations

Scientific Research Center of Obst., Gyn. and Perinatology

Moskva, Russia, 117997

Status
Completed
 
Locations

Scientific Research Center of Obst., Gyn. and Perinatology

Moscow, Russia, 177997

Status
Terminated
 
Locations

Municipal Hospital N 4

Moskva, Russia, 113093

Status
Completed
 
Locations

Moscow Regional Research Institue of Obstetrics & Gynecology

Moskva, Russia, 101000

Status
Completed
 
Locations

Praxis Dr. Langer

Fuerstenfeld, Austria, 8280

Status
Terminated
 
Locations

Dr. Max Stiglbauer

Wiener Neustadt, Austria, 2700

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Dr. Wolfgang Bartl

Wien, Austria, 1200

Status
Completed
 
Locations

Dr. Ewald Boschitsch

Wien, Austria, 1060

Status
Completed
 
Locations

Dr. Bernhard Svejda

Klagenfurt, Austria, 9020

Status
Completed
 
Locations

Landeskrankenhaus Bregenz

Bregenz, Austria, 6900

Status
Completed
 
Locations

Center for Clinical & Basic Research

Ballerup, Denmark, 2750

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

A.O.U. di Cagliari

Cagliari, Italy, 09124

Status
Completed
 
Locations

A.O.U. di Sassari

Sassari, Italy, 07100

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41124

Status
Completed
 
Locations

A.O.U. Maggiore della Carità

Novara, Italy, 28100

Status
Completed
 
Locations

31 State Hospital

Moscow, Russia, 117415

Status
Completed
 
Locations

Instituto Médico de Asistencia e Investigación

Buenos Aires, Argentina, C1117ABH

Status
Completed
 
Locations

Instituto Ginecologico Buenos Aires

Lanus Oeste, Argentina, 1824

Status
Completed
 
Locations

Clinica de la Mujer San Isidro Labrador - Ginec

San Isidro, Argentina, B1642CLN

Status
Completed
 
Locations

Hospital Británico

Buenos Aires, Argentina, C1280AEB

Status
Completed
 
Locations

Clinica de la Mujer San Isidro Labrador - Ginec

San Isidro, Argentina, B1642CLN

Status
Terminated
 
Locations

Hospital Moinhos de Vento-Centro Clínico

Porto Alegre, Brazil, 90035-001

Status
Terminated
 
Locations

Instituto de Saude e Bem Estar Mulher

Sao Paulo, Brazil, 04062-003

Status
Terminated
 
Locations

Fundación Médica Sur CIF BIOTEC

México, D.F., Mexico, 14050

Status
Completed
 
Locations

Rapid Medical Research Inc.

Cleveland, United States, 44122

Status
Completed
 
Locations

Clinical Trial Center of Colorado

Greenwood Village, United States, 80111

Status
Terminated
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

York Clinical Consulting

Marrero, United States, 70072

Status
Completed
 
Locations

Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

Status
Completed
 
Locations

Women's Medical Research Group, LLC

Clearwater, United States, 33759

Status
Completed
 
Locations

Advanced Research Associates

Corpus Christi, United States, 78414

Status
Completed
 
Locations

Centro Tiempo

Buenos Aires, Argentina, C1117ABH

Status
Completed
 
Locations

Centro de Estudos e Pesquisas em Reproducao Humana e Fertil.

Curitiba, Brazil, 80030-220

Status
Terminated
 
Locations

MAA Centro de Pesquisa Clinica

Goiania, Brazil, 74175-080

Status
Terminated
 
Locations

Instituto Nacional de Perinatología

Mexico, Mexico

Status
Completed
 
Locations

Hospital María José

Mexico, Mexico, 06700

Status
Completed
 
Locations

Hospital Universitario "José Eleuterio González"

Monterrey, Mexico, 64460

Status
Terminated
 
Locations

Visions Clinical Research

Boynton Beach, United States, 33437

Status
Terminated
 
Locations

Genesis Center for Clinical Research

San Diego, United States, 92103

Status
Completed
 
Locations

National Clinical Research, Inc.

Richmond, United States, 23294

Status
Completed
 
Locations

Dr. Yekaterina Khronusova, MD

Las Vegas, United States, 89122

Status
Terminated
 
Locations

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

Seattle, United States, 98105

Status
Completed
 
Locations

South Carolina Clinical Research Center

Columbia, United States, 29201

Status
Completed
 
Locations

York Clinical Consulting

Amite, United States, 70422

Status
Terminated
 
Locations

Downtown Women's Healthcare

Denver, United States, 80218

Status
Completed
 
Locations

Advanced Clinical Research

Boise, United States, 83704

Status
Completed
 
Locations

East Valley Family Physicians, PLC

Chandler, United States, 85224

Status
Completed
 

Trial Design