Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive
NCT ID: NCT02792504
Last Updated: 2021-08-05
Study Results
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View full resultsBasic Information
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COMPLETED
669 participants
OBSERVATIONAL
2016-03-29
2020-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. postmenopausal osteopenia
Exclusion Criteria
* Women with known, suspected, or past history of breast cancer
* Women with known or suspected estrogen-dependent neoplasia
* Women with active deep venous thrombosis, pulmonary embolism, or history of these conditions
* Women with active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions
* Women who are receiving progestin, estrogen, or estrogen-agonists/antagonists
* Women with hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients
* Women with known hepatic impairment or disease
* Women with known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders
* Pregnant women, women who may become pregnant, and nursing mothers
* Women with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
20 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Kyungpook National University/Department of Internal Medicine (Cardiology)
Jung-gu, Daegu, South Korea
Dr. Wang's OB & GY Clinic
Seoul, Dobong-gu, South Korea
Kimhyeonmi OBGY
Hwaseong-si, Dongtan, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Bucheon St. Mary Hospital The Catholic University of Korea
Bucheon-si, Gyeonggi-do, South Korea
Baylor Ewha Obgyn Clinic
Seongnam-si, Gyeonggi-do, South Korea
Dongguk University Ilsan Medical Center Obstetrics
Goyang-si, Ilsandong-gu, South Korea
Obstetrics / Grace Women's Hospital
Goyong-si, Ilsandong-gu, South Korea
Kyungpook National University Hospital, Obstetrics
Daegu, Jung-gu, South Korea
Pusan University Hospital Obstetrics
Pusan, Seo-gu, South Korea
Catholic Universith of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-gu, South Korea
Samsung Medical Center, Sungkyunkwan Univ. School of Medicine
Kangnam-ku, Seoul, South Korea
Konkuk University Medical Center
Seoul, , South Korea
Seoul National University Hospital / Department of Internal Medicine
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Sanggye Paik Hospital-Inje University
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Chungang University Hospital
Seoul, , South Korea
AJOU University Hospital
Suwon, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2311067
Identifier Type: -
Identifier Source: org_study_id
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