Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

• ClinicalTrials.gov Identifier: NCT02792504
• Recruitment Status: Completed
• First Posted: June 7, 2016
• Last Update Posted: October 5, 2020
• Sponsor: Pfizer
• 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
• 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

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

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