Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

Completed

Conditions: Severe Vasomotor Symptom Associated With Menopause

Registration Number: NCT02792504

Lead Sponsor: Pfizer

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 669

Inclusion Criteria

Severe post menopausal vasomotor symptoms with uterus
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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit	Baseline, Last visit (last visit was anytime up to a maximum of Month 21)	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.
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6	Baseline, 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.
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6	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.
Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to 28 days after last dose of study drug (up to 22 months)	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.
Number of Participants Classified According to Measures Taken for Adverse Events	Baseline up to 28 days after last dose of study drug (up to 22 months)	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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to 28 days after last dose of study drug (up to 22 months)	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.
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3	Baseline, 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.
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3	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.
Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit	Last visit (last visit was anytime up to a maximum of Month 21)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (19): Kyungpook National University/Department of Internal Medicine (Cardiology)
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Jung-gu, Daegu, Korea, Republic of
Obstetrics / Grace Women's Hospital
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Goyong-si, Ilsandong-gu, Korea, Republic of
Dr. Wang's OB & GY Clinic
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Seoul, Dobong-gu, Korea, Republic of
Bucheon St. Mary Hospital The Catholic University of Korea
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Bucheon-si, Gyeonggi-do, Korea, Republic of
Pusan University Hospital Obstetrics
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Pusan, Seo-gu, Korea, Republic of
Seoul National University Hospital / Department of Internal Medicine
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Seoul, Korea, Republic of
Sanggye Paik Hospital-Inje University
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Seoul, Korea, Republic of
Korea University Ansan Hospital
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Ansan, Gyeonggi-do, Korea, Republic of
Samsung Medical Center, Sungkyunkwan Univ. School of Medicine
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Kangnam-ku, Seoul, Korea, Republic of
Asan Medical Center
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Seoul, Korea, Republic of
Kimhyeonmi OBGY
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Hwaseong-si, Dongtan, Korea, Republic of
Dongguk University Ilsan Medical Center Obstetrics
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Goyang-si, Ilsandong-gu, Korea, Republic of
Kyungpook National University Hospital, Obstetrics
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Daegu, Jung-gu, Korea, Republic of
Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republic of
Baylor Ewha Obgyn Clinic
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Seongnam-si, Gyeonggi-do, Korea, Republic of
Catholic Universith of Korea, Seoul ST. Mary's Hospital
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Seoul, Seocho-gu, Korea, Republic of
AJOU University Hospital
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Suwon, Korea, Republic of
Konkuk University Medical Center
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Seoul, Korea, Republic of
Chungang University Hospital
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Seoul, Korea, Republic of