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Trial record 1 of 1 for:    NCT02792504
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Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02792504
Recruitment Status : Completed
First Posted : June 7, 2016
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 19, 2016
First Posted Date June 7, 2016
Last Update Posted Date October 5, 2020
Actual Study Start Date March 29, 2016
Actual Primary Completion Date July 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2016)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 30 days after last dose ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Percentage of participants discontinued from study
  • Vasomotor System Assessment [ Time Frame: 30 days after last dose ]
    Measured as follows (improved, no change, aggravated), investigators judgment on the improvement of the symptom recorded during the treatment.
  • Osteopenia Assessment [ Time Frame: 30 days after last dose ]
    Measured as follows (improved, no change, aggravated), investigators judgment on clincal response at post treatment and relevant lab data(if collected)from medical record during the treatment.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Completed
Actual Enrollment
 (submitted: October 1, 2020)
669
Original Estimated Enrollment
 (submitted: June 1, 2016)
600
Actual Study Completion Date July 22, 2020
Actual Primary Completion Date July 22, 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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2020