Severe Vasomotor Symptom Associated With MenopauseNCT02792504
Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive
An observational study of Severe Vasomotor Symptom Associated With Menopause, run by Pfizer at 20 sites in South Korea.
Trial summary
To evaluate safety and efficacy of CE/BZA in real practice in Korea Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Severe Vasomotor Symptom Associated With Menopause
- How many people
- 669 participants
- Where
- 20 sitesSouth Korea
- Study dates
- 29 Mar 2016to 22 Jul 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: General hospital and Primary clinic in Korea
Who may be able to join
- Severe post menopausal vasomotor symptoms with uterus
- postmenopausal osteopenia
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 425-707
Bucheon St. Mary Hospital The Catholic University of Korea
Bucheon-si, Gyeonggi-do, 14647
Kyungpook National University Hospital, Obstetrics
Daegu, Jung-gu, 41940
Dongguk University Ilsan Medical Center Obstetrics
Goyang-si, Ilsandong-gu, 10326
Obstetrics / Grace Women's Hospital
Goyong-si, Ilsandong-gu, 10447
Kimhyeonmi OBGY
Hwaseong-si, Dongtan, 18442
Kyungpook National University/Department of Internal Medicine (Cardiology)
Jung-gu, Daegu, 700-721
Samsung Medical Center, Sungkyunkwan Univ. School of Medicine
Kangnam-ku, Seoul, 135-710
Pusan University Hospital Obstetrics
Pusan, Seo-gu, 602 739
Baylor Ewha Obgyn Clinic
Seongnam-si, Gyeonggi-do, 463-811
Dr. Wang's OB & GY Clinic
Seoul, Dobong-gu, 01432
Catholic Universith of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-gu, 06591
Konkuk University Medical Center
Seoul, 05030
Seoul National University Hospital / Department of Internal Medicine
Seoul, 110-744
Severance Hospital, Yonsei University Health System
Seoul, 120-752
Asan Medical Center
Seoul, 138 736
Sanggye Paik Hospital-Inje University
Seoul, 139-707
Konkuk University Medical Center
Seoul, 143-729
Chungang University Hospital
Seoul, 156-755
AJOU University Hospital
Suwon, 443-380
About this study
Official title: 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Last visit (last visit was anytime up to a maximum of Month 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start29 Mar 2016
- Primary completion22 Jul 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Vasomotor Symptom Associated With MenopauseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792504
- Sponsor's protocol ID
- B2311067
- Status last verified
- Jul 2021
- First submitted
- 19 Feb 2016
- Last updated
- 5 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POST MARKETING SURVEILLANCE TO OBSERVE THE SAFETY AND EFFICACY OF DUAVIVE TAB 0.45MG/20MG
- ClinicalTrials.gov ID
- NCT02792504
- Acronym / sponsor ID
- B2311067
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Posted 5 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate safety and efficacy of CE/BZA in real practice in Korea
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General hospital and Primary clinic in Korea
Key inclusion criteria (2 listed)
- Severe post menopausal vasomotor symptoms with uterus
- postmenopausal osteopenia
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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 Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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
Time frame: 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 Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3
Time frame: 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 Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6
Time frame: 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.
Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit
Time frame: 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 Prevention of Post-menopausal Osteoporosis at Month 3
Time frame: 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.
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6
Time frame: 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.
Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Vasomotor Symptom Associated With Menopause, run by Pfizer at 20 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 28 days after last dose of study drug (up to 22 months)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.