Trial Outcomes & Findings for A Study to Learn More About the Menopausal Hormone Therapies in Korea (NCT NCT06033521)
NCT ID: NCT06033521
Last Updated: 2025-04-18
Results Overview
Menopausal symptoms: at least one inpatient or outpatient claim with any of diagnosis codes based on Korean standard classification of disease, 8th revision(KCD-8):Korean version of ICD-10(International statistical classification of diseases and related health problems,10th revision), per protocol. N95.1: Menopausal, female climacteric states; N95.2:Postmenopausal atrophic vaginitis; N95.3:States associated with artificial menopause; N95.8 Other specified menopausal, perimenopausal disorders; N95.9: Menopausal, perimenopausal disorder, unspecified; M80.0: Postmenopausal osteoporosis with pathological fracture;M81.0: Postmenopausal osteoporosis; M81.99:Osteoporosis, unspecified, site unspecified; Osteopenia; M85.99: Disorder of bone density, structure, unspecified, site unspecified; Osteopenia, mild; Osteopenia, moderate; Osteopenia, severe. One participant could have visited hospital for \>=1 time for different menopausal symptom. Index date: date of first prescription for MHT.
COMPLETED
1036294 participants
Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months
2025-04-18
Participant Flow
Data for female participants in South Korea, aged 40-59 years who had diagnosis of menopausal symptoms and/or received menopausal hormone therapy (MHT), was retrieved from Health Insurance and Review Assessment (HIRA) database from 1-January-2016 and 31-Decemeber-2020 (included follow-up duration). Retrospective available data was evaluated as per objectives of this study from 12-September-2023 to 11-March-2024 (approximately 6 months).
Participant milestones
| Measure |
All Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and/or received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Overall Study
STARTED
|
1036294
|
|
Overall Study
COMPLETED
|
1036294
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Age, Continuous
|
52.53 Years
STANDARD_DEVIATION 4.14 • n=1036294 Participants
|
|
Sex: Female, Male
Female
|
1036294 Participants
n=1036294 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1036294 Participants
|
PRIMARY outcome
Timeframe: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
Menopausal symptoms: at least one inpatient or outpatient claim with any of diagnosis codes based on Korean standard classification of disease, 8th revision(KCD-8):Korean version of ICD-10(International statistical classification of diseases and related health problems,10th revision), per protocol. N95.1: Menopausal, female climacteric states; N95.2:Postmenopausal atrophic vaginitis; N95.3:States associated with artificial menopause; N95.8 Other specified menopausal, perimenopausal disorders; N95.9: Menopausal, perimenopausal disorder, unspecified; M80.0: Postmenopausal osteoporosis with pathological fracture;M81.0: Postmenopausal osteoporosis; M81.99:Osteoporosis, unspecified, site unspecified; Osteopenia; M85.99: Disorder of bone density, structure, unspecified, site unspecified; Osteopenia, mild; Osteopenia, moderate; Osteopenia, severe. One participant could have visited hospital for \>=1 time for different menopausal symptom. Index date: date of first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year
2016
|
786616 Participants
|
|
Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year
2017
|
787425 Participants
|
|
Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year
2018
|
791890 Participants
|
|
Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year
2019
|
818749 Participants
|
PRIMARY outcome
Timeframe: Index Date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
Number of Women with MHT use distributed per year was reported in this outcome measure. One participant could have taken more than 1 type of MHT hence participants are not fully exclusive. Three types of MHT included ET (estrogen therapy), EPT (estrogen-progestin therapy), and tibolone. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Number of Women With MHT Use Distributed Per Year
2016
|
446702 Participants
|
|
Number of Women With MHT Use Distributed Per Year
2017
|
473592 Participants
|
|
Number of Women With MHT Use Distributed Per Year
2018
|
481568 Participants
|
|
Number of Women With MHT Use Distributed Per Year
2019
|
494192 Participants
|
PRIMARY outcome
Timeframe: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable at specified rows.
Menopausal symptoms included vasomotor, bone and joint, genitourinary and psychosomatic. One participant could have more than 1 type of menopausal symptoms. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Vasomotor: 2016
|
358505 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Bone and joint: 2016
|
28208 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Genitourinary: 2016
|
80857 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Psychosomatic: 2016
|
1809 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Vasomotor: 2017
|
119084 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Bone and joint: 2017
|
8396 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Genitourinary: 2017
|
57812 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Psychosomatic: 2017
|
780 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Vasomotor: 2018
|
92169 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Bone and joint: 2018
|
6635 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Genitourinary: 2018
|
48640 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Psychosomatic: 2018
|
648 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Vasomotor: 2019
|
85728 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Bone and joint: 2019
|
6025 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Genitourinary: 2019
|
42798 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
Psychosomatic: 2019
|
652 Participants
|
PRIMARY outcome
Timeframe: Index Date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable at specified rows.
Menopausal symptoms included vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, psychosomatic symptoms for systemic, Estrogen Therapy (ET), Estrogen-Progestin Therapy (EPT) and Tibolone. One participant could have more than 1 type of menopausal symptoms and have received more than 1 type of therapy. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
Systemic MHT: Vasomotor symptoms
|
649307 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
Systemic MHT: Bone and joint symptoms
|
83856 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
Systemic MHT: Genitourinary symptoms
|
44385 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
Systemic MHT: Psychosomatic symptoms
|
4951 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
ET: Vasomotor symptoms
|
80044 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
ET: Bone and joint symptoms
|
12479 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
ET: Genitourinary symptoms
|
8087 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
ET: Psychosomatic symptoms
|
710 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
EPT: Vasomotor symptoms
|
287092 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
EPT: Bone and joint symptoms
|
30659 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
EPT: Genitourinary symptoms
|
16825 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
EPT: Psychosomatic symptoms
|
2241 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
Tibolone: Vasomotor symptoms
|
283069 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
Tibolone: Bone and joint symptoms
|
40833 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
Tibolone: Genitourinary symptoms
|
19581 Participants
|
|
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
Tibolone: Psychosomatic symptoms
|
2021 Participants
|
PRIMARY outcome
Timeframe: Index Date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
Number of participants with use of any MHT according to age group were reported in this outcome measure. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Number of Participants With Use of Any MHT According to Age Group
40-44 Years
|
39917 Participants
|
|
Number of Participants With Use of Any MHT According to Age Group
45-49 Years
|
199389 Participants
|
|
Number of Participants With Use of Any MHT According to Age Group
50-54 Years
|
425030 Participants
|
|
Number of Participants With Use of Any MHT According to Age Group
55-59 Years
|
371958 Participants
|
PRIMARY outcome
Timeframe: Index Date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
Number of participants with MHT according to type of administration were reported in this outcome measure. Type of administration included systemic hormone therapy (HT) (oral), systemic HT (transdermal), local HT (transvaginal). One participant could have received more than 1 type of therapy. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Number of Participants With MHT According to Type of Administration
Systemic MHT (oral)
|
693072 Participants
|
|
Number of Participants With MHT According to Type of Administration
Systemic MHT (transdermal)
|
2960 Participants
|
|
Number of Participants With MHT According to Type of Administration
Local MHT (transvaginal)
|
378764 Participants
|
PRIMARY outcome
Timeframe: Month 3 post-index date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
Percentage of participants with change in treatment regimen at Month 3 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 3
Systemic ET
|
5.8 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 3
EPT
|
17.6 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 3
Tibolone
|
20.4 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 3
Local ET
|
4.1 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 3
No treatment provided
|
52.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 6 post-index date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
Percentage of participants with change in treatment regimen at Month 6 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 6
Systemic ET
|
4.3 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 6
EPT
|
11.0 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 6
Tibolone
|
14.0 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 6
Local ET
|
0.9 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 6
No treatment provided
|
69.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 9 post-index date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
Percentage of participants with change in treatment regimen at Month 9 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 9
Systemic ET
|
3.5 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 9
EPT
|
8.5 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 9
Tibolone
|
11.1 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 9
Local ET
|
0.6 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 9
No treatment provided
|
76.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 12 post-index date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
Percentage of participants with change in treatment regimen at Month 12 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 12
Systemic ET
|
3.0 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 12
EPT
|
7.0 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 12
Tibolone
|
9.4 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 12
Local ET
|
0.5 Percentage of participants
|
|
Percentage of Participants With Change in Treatment Regimen Change at Month 12
No treatment provided
|
80.1 Percentage of participants
|
PRIMARY outcome
Timeframe: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Time to discontinuation was defined as no subsequent prescriptions within 2 months of last prescription date. MHT included: Systemic MHT: ET, EPT, Tibolone and Local MHT: ET. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Time to Discontinuation of MHT
Systemic MHT: ET
|
14.4 Months
Standard Deviation 17.7
|
|
Time to Discontinuation of MHT
Systemic MHT: EPT
|
10.1 Months
Standard Deviation 13.7
|
|
Time to Discontinuation of MHT
Systemic MHT: Tibolone
|
13.4 Months
Standard Deviation 16.6
|
|
Time to Discontinuation of MHT
Local MHT: ET
|
2.4 Months
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Time to switching of MHT was reported in this outcome measure. Participants who switched the treatment classes were included. MHT included: Systemic MHT: ET, EPT, Tibolone and Local MHT: ET. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Time to Switching of MHT
Systemic MHT: ET
|
13.2 Months
Standard Deviation 15.0
|
|
Time to Switching of MHT
Systemic MHT: EPT
|
16.9 Months
Standard Deviation 15.5
|
|
Time to Switching of MHT
Systemic MHT: Tibolone
|
13.9 Months
Standard Deviation 14.7
|
|
Time to Switching of MHT
Local MHT: ET
|
7.1 Months
Standard Deviation 11.7
|
PRIMARY outcome
Timeframe: Month 3 post-index; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type
Systemic MHT: ET
|
69.5 Percentage of participants
Interval to 22.1
|
|
Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type
Systemic MHT: EPT
|
60.9 Percentage of participants
Interval 3.2 to 27.7
|
|
Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type
Systemic MHT: Tibolone
|
75.8 Percentage of participants
Interval 1.2 to 22.5
|
|
Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type
Local MHT: ET
|
11.8 Percentage of participants
Interval 0.0 to 10.6
|
PRIMARY outcome
Timeframe: Month 6 post-index; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type
Systemic MHT: ET
|
48.2 Percentage of participants
Interval to 22.1
|
|
Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type
Systemic MHT: EPT
|
36.7 Percentage of participants
Interval 3.2 to 27.7
|
|
Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type
Systemic MHT: Tibolone
|
46.4 Percentage of participants
Interval 1.2 to 22.5
|
|
Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type
Local MHT: ET
|
1.1 Percentage of participants
Interval 0.0 to 10.6
|
PRIMARY outcome
Timeframe: Month 9 post-index; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type
Systemic MHT: ET
|
38.7 Percentage of participants
Interval to 22.1
|
|
Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type
Systemic MHT: EPT
|
27.9 Percentage of participants
Interval 3.2 to 27.7
|
|
Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type
Systemic MHT: Tibolone
|
36.4 Percentage of participants
Interval 1.2 to 22.5
|
|
Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type
Local MHT: ET
|
0.4 Percentage of participants
Interval 0.0 to 10.6
|
PRIMARY outcome
Timeframe: Month 12 post-index; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type
Systemic MHT: ET
|
33.1 Percentage of participants
Interval to 22.1
|
|
Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type
Systemic MHT: EPT
|
22.6 Percentage of participants
Interval 3.2 to 27.7
|
|
Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type
Systemic MHT: Tibolone
|
30.3 Percentage of participants
Interval 1.2 to 22.5
|
|
Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type
Local MHT: ET
|
0.2 Percentage of participants
Interval 0.0 to 10.6
|
PRIMARY outcome
Timeframe: Index Date; retrospective data observed in this study for approximately 6 monthsPopulation: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Treatment adherence was evaluated using medication possession ratio (MPR), calculated as the total number of days of medication supply divided by the number of days in the follow-up period. Data for this outcome is expressed in percentage. Index date was defined as the date of the first prescription for MHT.
Outcome measures
| Measure |
Participants With MHT
n=1036294 Participants
Female participants aged 40-59 years who had diagnosis of menopausal symptoms and received MHT in real-world practice. No intervention was administered during this study.
|
|---|---|
|
Mean Treatment Adherence (%)
Systemic MHT: ET
|
37.3 Percentage of days
Standard Deviation 45.5
|
|
Mean Treatment Adherence (%)
Systemic MHT: EPT
|
22.4 Percentage of days
Standard Deviation 39.0
|
|
Mean Treatment Adherence (%)
Systemic MHT: Tibolone
|
35.5 Percentage of days
Standard Deviation 55.0
|
|
Mean Treatment Adherence (%)
Local MHT: ET
|
3.1 Percentage of days
Standard Deviation 27.2
|
Adverse Events
Participants With MHT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER