check_circleStudy Completed
Postmenopause
Bayer Identifier:
91508
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Endometrial safety study
Trial purpose
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
Key Participants Requirements
Sex
FemaleAge
40 - 65 YearsTrial summary
Enrollment Goal
662Trial Dates
August 2007 - August 2009Phase
Phase 3Could I Receive a placebo
NoProducts
Low-Dose E2/DRSP (BAY86-4891)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dr. Guenther Heytmanek | Wien, 1030, Austria |
Completed | Praxis Dr. Wollein | Mödling, 2340, Austria |
Completed | Praxis Dr. Norman Ruth | Wörgl, 6300, Austria |
Completed | Dr. Sigrid Schmidl-Amann | St. Poelten, 3100, Austria |
Terminated | Dr. Walter Paulik | Zeltweg, 8740, Austria |
Completed | Universitätsklinikum Innsbruck | Innsbruck, 6020, Austria |
Completed | Praxis Fr. Dr. Barbara Eberz | Mürzzuschlag, 8680, Austria |
Completed | Center for Clinical& Basic Research | Alborg, 9000, Denmark |
Completed | Center for Clinical & Basic Research | Vejle, 7100, Denmark |
Completed | A.O.U. Senese | Siena, 53100, Italy |
Completed | A.O.U. di Bologna | Bologna, 40138, Italy |
Completed | A.O.U. di Parma | Parma, 43100, Italy |
Completed | Scientific Research Center of Obst., Gyn. and Perinatology | Moskva, 117997, Russia |
Terminated | Scientific Research Center of Obst., Gyn. and Perinatology | Moscow, 177997, Russia |
Completed | Municipal Hospital N 4 | Moskva, 113093, Russia |
Completed | Moscow Regional Research Institue of Obstetrics & Gynecology | Moskva, 101000, Russia |
Terminated | Praxis Dr. Langer | Fuerstenfeld, 8280, Austria |
Completed | Dr. Max Stiglbauer | Wiener Neustadt, 2700, Austria |
Completed | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Completed | Dr. Wolfgang Bartl | Wien, 1200, Austria |
Completed | Dr. Ewald Boschitsch | Wien, 1060, Austria |
Completed | Dr. Bernhard Svejda | Klagenfurt, 9020, Austria |
Completed | Landeskrankenhaus Bregenz | Bregenz, 6900, Austria |
Completed | Center for Clinical & Basic Research | Ballerup, 2750, Denmark |
Completed | A.O.U. Pisana | Pisa, 56126, Italy |
Completed | A.O.U. di Cagliari | Cagliari, 09124, Italy |
Completed | A.O.U. di Sassari | Sassari, 07100, Italy |
Completed | A.O.U. di Modena Policlinico | Modena, 41124, Italy |
Completed | A.O.U. Maggiore della Carità | Novara, 28100, Italy |
Completed | 31 State Hospital | Moscow, 117415, Russia |
Completed | Instituto Médico de Asistencia e Investigación | Buenos Aires, C1117ABH, Argentina |
Completed | Instituto Ginecologico Buenos Aires | Lanus Oeste, 1824, Argentina |
Completed | Clinica de la Mujer San Isidro Labrador - Ginec | San Isidro, B1642CLN, Argentina |
Completed | Hospital Británico | Buenos Aires, C1280AEB, Argentina |
Terminated | Clinica de la Mujer San Isidro Labrador - Ginec | San Isidro, B1642CLN, Argentina |
Terminated | Hospital Moinhos de Vento-Centro Clínico | Porto Alegre, 90035-001, Brazil |
Terminated | Instituto de Saude e Bem Estar Mulher | Sao Paulo, 04062-003, Brazil |
Completed | Fundación Médica Sur CIF BIOTEC | México, D.F., 14050, Mexico |
Completed | Rapid Medical Research Inc. | Cleveland, 44122, United States |
Terminated | Clinical Trial Center of Colorado | Greenwood Village, 80111, United States |
Completed | Medical Center for Clinical Research | San Diego, 92108, United States |
Completed | York Clinical Consulting | Marrero, 70072, United States |
Completed | Clinical Research of Philadelphia, LLC | Philadelphia, 19114, United States |
Completed | Women's Medical Research Group, LLC | Clearwater, 33759, United States |
Completed | Advanced Research Associates | Corpus Christi, 78414, United States |
Completed | Centro Tiempo | Buenos Aires, C1117ABH, Argentina |
Terminated | Centro de Estudos e Pesquisas em Reproducao Humana e Fertil. | Curitiba, 80030-220, Brazil |
Terminated | MAA Centro de Pesquisa Clinica | Goiania, 74175-080, Brazil |
Completed | Instituto Nacional de Perinatología | Mexico, Mexico |
Completed | Hospital María José | Mexico, 06700, Mexico |
Terminated | Hospital Universitario "José Eleuterio González" | Monterrey, 64460, Mexico |
Terminated | Visions Clinical Research | Boynton Beach, 33437, United States |
Completed | Genesis Center for Clinical Research | San Diego, 92103, United States |
Completed | National Clinical Research, Inc. | Richmond, 23294, United States |
Terminated | Dr. Yekaterina Khronusova, MD | Las Vegas, 89122, United States |
Completed | Women's Clinical Research Center DBA Seattle Women's Health | Seattle, 98105, United States |
Completed | South Carolina Clinical Research Center | Columbia, 29201, United States |
Terminated | York Clinical Consulting | Amite, 70422, United States |
Completed | Downtown Women's Healthcare | Denver, 80218, United States |
Completed | Advanced Clinical Research | Boise, 83704, United States |
Completed | East Valley Family Physicians, PLC | Chandler, 85224, United States |
Primary Outcome
- 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)date_rangeTime Frame:Up to one yearenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Number of participants with amenorrhea during month 1 to 3 of treatmentdate_rangeTime Frame:Month 1 to Month 3enhanced_encryptionYesSafety Issue:
- Number of participants with amenorrhea during month 10 to 12 of treatmentdate_rangeTime Frame:Month 10 to Month 12enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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