Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

POST MARKETING SURVEILLANCE TO OBSERVE THE SAFETY AND EFFICACY OF DUAVIVE TAB 0.45MG/20MG

To evaluate safety and efficacy of CE/BZA in real practice in Korea

Study Overview

• Status: Completed
• Conditions: Severe Vasomotor Symptom Associated With Menopause

• Study Type: Observational
• Enrollment (Actual): 669

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital / Department of Internal Medicine
  • Seoul, Korea, Republic of, 138 736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 139-707
    • Sanggye Paik Hospital-Inje University
  • Seoul, Korea, Republic of, 156-755
    • Chungang University Hospital
  • Suwon, Korea, Republic of, 443-380
    • Ajou University Hospital
  • Daegu
    • Jung-gu, Daegu, Korea, Republic of, 700-721
      • Kyungpook National University/Department of Internal Medicine (Cardiology)
  • Dobong-gu
    • Seoul, Dobong-gu, Korea, Republic of, 01432
      • Dr. Wang's OB & GY Clinic
  • Dongtan
    • Hwaseong-si, Dongtan, Korea, Republic of, 18442
      • Kimhyeonmi OBGY
  • Gyeonggi-do
    • Ansan, Gyeonggi-do, Korea, Republic of, 425-707
      • Korea University Ansan Hospital
    • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
      • Bucheon St. Mary Hospital The Catholic University of Korea
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-811
      • Baylor Ewha Obgyn Clinic
  • Ilsandong-gu
    • Goyang-si, Ilsandong-gu, Korea, Republic of, 10326
      • Dongguk University Ilsan Medical Center Obstetrics
    • Goyong-si, Ilsandong-gu, Korea, Republic of, 10447
      • Obstetrics / Grace Women's Hospital
  • Jung-gu
    • Daegu, Jung-gu, Korea, Republic of, 41940
      • Kyungpook National University Hospital, Obstetrics
  • Seo-gu
    • Pusan, Seo-gu, Korea, Republic of, 602 739
      • Pusan University Hospital Obstetrics
  • Seocho-gu
    • Seoul, Seocho-gu, Korea, Republic of, 06591
      • Catholic Universith of Korea, Seoul ST. Mary's Hospital
  • Seoul
    • Kangnam-ku, Seoul, Korea, Republic of, 135-710
      • Samsung Medical Center, Sungkyunkwan Univ. School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

General hospital and Primary clinic in Korea

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events.	Baseline up to 28 days after last dose of study drug (up to 22 months)
Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. A treatment-related adverse event was any untoward medical occurrence attributed to Duavive tablet in a participant who received Duavive tablet. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Duavive tablet was assessed by the investigator.	Baseline up to 28 days after last dose of study drug (up to 22 months)
Number of Participants Classified According to Measures Taken for Adverse Events	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Following measures were taken for AEs in relation to Duavive tablet: no change in treatment, permanently discontinued treatment and temporarily discontinued treatment.	Baseline up to 28 days after last dose of study drug (up to 22 months)
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3	Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated.	Baseline, Month 3
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6	Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated.	Baseline, Month 6
Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit	Improvement from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved.	Baseline, Last visit (last visit was anytime up to a maximum of Month 21)
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3	Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.	Month 3
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6	Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.	Month 6
Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit	Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.	Last visit (last visit was anytime up to a maximum of Month 21)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2016
• Primary Completion (Actual): July 22, 2020
• Study Completion (Actual): July 22, 2020

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B2311067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.