Severe Vasomotor Symptom Associated With Menopause
Conditions
Brief summary
To evaluate safety and efficacy of CE/BZA in real practice in Korea
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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. |
| 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. |
| 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. |
Countries
South Korea
Participant flow
Recruitment details
This observational study was conducted in Korea. Enrolled participants included were administered with Duavive tablet 0.45 milligram (mg)/20 mg (conjugated estrogens 0.45 mg, bazedoxifene acetate 20 mg) for the first time as a part of routine treatment after the start of the study at a study site and complied with the local labeling. Participants were planned to be evaluated for 3 months, 6 months or more depending upon till when Duavive tablet was administered based on investigator's judgement.
Pre-assignment details
In this study no screening was performed. Women participants who were administered Duavive tablet were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Duavive Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document. | 639 |
| Total | 639 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Violated inclusion/exclusion criteria | 6 |
Baseline characteristics
| Characteristic | Duavive | — |
|---|---|---|
| Age, Continuous | 53.65 years STANDARD_DEVIATION 5.59 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 639 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 639 |
| other Total, other adverse events | 71 / 639 |
| serious Total, serious adverse events | 2 / 639 |
Outcome results
Primary
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.
Time frame: Baseline up to 28 days after last dose of study drug (up to 22 months)
Population: Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up. Here, Overall Number of Participants Analyzed signifies number of participants with adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Duavive | Number of Participants Classified According to Measures Taken for Adverse Events | No change in treatment | 19 Participants |
| Duavive | Number of Participants Classified According to Measures Taken for Adverse Events | Permanently discontinued treatment | 53 Participants |
| Duavive | Number of Participants Classified According to Measures Taken for Adverse Events | Temporarily discontinued treatment | 1 Participants |
Primary
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.
Time frame: Baseline up to 28 days after last dose of study drug (up to 22 months)
Population: Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Duavive | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 73 Participants |
| Duavive | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 Participants |
Primary
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.
Time frame: Baseline, Month 3
Population: Efficacy analysis set (EAS) of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure at Month 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Duavive | Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3 | Effectiveness | 319 Participants |
| Duavive | Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3 | Ineffectiveness | 68 Participants |
Primary
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.
Time frame: Baseline, Month 6
Population: EAS of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure at Month 6.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Duavive | Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6 | Effectiveness | 118 Participants |
| Duavive | Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6 | Ineffectiveness | 23 Participants |
Primary
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.
Time frame: Month 3
Population: EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duavive | Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3 | 17 Participants |
Primary
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.
Time frame: Month 6
Population: EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis. Here, Overall number of participants analyzed = participants who were administered with Duavive tablet for prevention of postmenopausal osteoporosis at Month 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duavive | Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6 | 1 Participants |
Primary
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.
Time frame: Baseline up to 28 days after last dose of study drug (up to 22 months)
Population: Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Duavive | Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment Related AEs | 58 Participants |
| Duavive | Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment Related SAEs | 0 Participants |
Primary
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.
Time frame: Baseline, Last visit (last visit was anytime up to a maximum of Month 21)
Population: EAS of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duavive | Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit | 82.31 percentage of participants |
Primary
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.
Time frame: Last visit (last visit was anytime up to a maximum of Month 21)
Population: EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duavive | Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit | 77.27 percentage of participants |