Clinical trial NCT02792504: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Vasomotor Symptom Associated With Menopause
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 669
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General hospital and Primary clinic in Korea

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


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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose of study drug (up to 22 months)
measure: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose of study drug (up to 22 months)
measure: Number of Participants Classified According to Measures Taken for Adverse Events
timeFrame: Baseline up to 28 days after last dose of study drug (up to 22 months)
measure: Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3
timeFrame: Baseline, Month 3
measure: Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6
timeFrame: Baseline, Month 6
measure: Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit
timeFrame: Baseline, Last visit (last visit was anytime up to a maximum of Month 21)
measure: Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3
timeFrame: Month 3
measure: Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit
timeFrame: Last visit (last visit was anytime up to a maximum of Month 21)
Secondary outcomes:
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University/Department of Internal Medicine (Cardiology)
state: Daegu
city: Seoul
country: Korea, Republic of
facility: Dr. Wang's OB & GY Clinic
state: Dobong-gu
city: Hwaseong-si
country: Korea, Republic of
facility: Kimhyeonmi OBGY
state: Dongtan
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Bucheon-si
country: Korea, Republic of
facility: Bucheon St. Mary Hospital The Catholic University of Korea
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Baylor Ewha Obgyn Clinic
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Medical Center Obstetrics
state: Ilsandong-gu
city: Goyong-si
country: Korea, Republic of
facility: Obstetrics / Grace Women's Hospital
state: Ilsandong-gu
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital, Obstetrics
state: Jung-gu
city: Pusan
country: Korea, Republic of
facility: Pusan University Hospital Obstetrics
state: Seo-gu
city: Seoul
country: Korea, Republic of
facility: Catholic Universith of Korea, Seoul ST. Mary's Hospital
state: Seocho-gu
city: Kangnam-ku
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan Univ. School of Medicine
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital / Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Sanggye Paik Hospital-Inje University
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Chungang University Hospital
city: Suwon
country: Korea, Republic of
facility: AJOU University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: