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Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

Last updated on March 25, 2020

FOR MORE INFORMATION
Study Location
Dr. Wang's OB & GY Clinic
Seoul, Dobong-gu, 01432 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Severe Vasomotor Symptom Associated With Menopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Severe post menopausal vasomotor symptoms with uterus

2. postmenopausal osteopenia

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Women with undiagnosed abnormal uterine bleeding

- 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.

NCT02792504
Pfizer
Active, not recruiting
Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

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Descriptive Information
Brief Title Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive
Official Title POST MARKETING SURVEILLANCE TO OBSERVE THE SAFETY AND EFFICACY OF DUAVIVE TAB 0.45MG/20MG
Brief Summary To evaluate safety and efficacy of CE/BZA in real practice in Korea
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population General hospital and Primary clinic in Korea
Condition Severe Vasomotor Symptom Associated With Menopause
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 1, 2016)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Severe post menopausal vasomotor symptoms with uterus
  2. postmenopausal osteopenia

Exclusion Criteria:

  • Women with undiagnosed abnormal uterine bleeding
  • 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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02792504
Other Study ID Numbers B2311067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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