check_circleStudy Completed
Postmenopause
Bayer Identifier:infoA unique number for a trial given by Bayer.
91508
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
662The overall number of participants needed for a trial.
Trial Dates info
August 2007 - August 2009Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Low-Dose E2/DRSP (BAY86-4891)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where 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 OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 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 info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Double Blind“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
2A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.
Additional Information
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