Bone Demineralization, Menopause
Conditions
Keywords
Menopause, Bone Demineralization, Hormone Replacement Therapy
Brief summary
The purpose of this study is to learn about how the commonly used menopausal hormone therapies were prescribed and taken in practice. This is done by using healthcare database, to study the overall dangers and benefits of menopausal hormone therapies in real-world practice. This study will include subjects who were newly diagnosed menopausal symptoms between 2012 and 2019. They were all followed up for 12 months at least. The study included the below subjects who: * were aged 40-59 years * were diagnosed to have menopausal symptoms through some medical check-ups The data collected will be used to understand: * how the commonly used menopausal hormone therapies were prescribed and taken in practice * how patients took medication as prescribed by their doctors This might help to understand treatment trends of these therapies.
Interventions
DRUGMenopausal hormone therapy Intervention Type: Drug
Subjects who were newly diagnosed menopausal symptoms between 01 Jan 2012 and 31 Dec 2019, and were followed up for 12 months at least in the HIRA claims database
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 40-59 years at cohort entry date * Patients who had at least one inpatient or outpatient diagnosis of menopausal symptoms between 01 Jan 2012 and 31 Dec 2019 with any of following diagnosis codes: N95.1, N95.2, N95.3, N95.8, N95.9, M80.0, M81.0, M81.99, M85.99
Exclusion criteria
* Patients diagnosed with breast cancer (C50, D05), endometrial cancer (C54.1), and granulosa cell tumor (C56) within 1 year prior to the index date. * Patients diagnosed with coronary heart disease (I20-I25, I51.6), stroke (I60-64), and VTE (I80.2, I80.3 I26) within 1 year prior to the index date. * Patients diagnosed with viral hepatitis (B16-B19), cirrhosis (K70.2-K70.4, K71.7, K72.0-K72.1, K72.9, K74.0-K74.6, K76.1, K76.6-K76.7, R18, I85.0, I85.9, I86.4, I86.8, I98.2-I98.3), and hepatic cancer (C22) within 1 year prior to the index date. * Patients diagnosed with gallbladder disease (K80, K81, K82, K83, K85.1), gallbladder cancer (C23), extrahepatic bile duct cancer (C24) within 1 year prior to the index date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year | Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months | 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. |
| Number of Women With MHT Use Distributed Per Year | Index Date; retrospective data observed in this study for approximately 6 months | 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. |
| Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months | 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. |
| Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Index Date; retrospective data observed in this study for approximately 6 months | 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. |
| Number of Participants With Use of Any MHT According to Age Group | Index Date; retrospective data observed in this study for approximately 6 months | 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. |
| Number of Participants With MHT According to Type of Administration | Index Date; retrospective data observed in this study for approximately 6 months | 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. |
| Percentage of Participants With Change in Treatment Regimen Change at Month 3 | Month 3 post-index date; retrospective data observed in this study for approximately 6 months | 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. |
| Percentage of Participants With Change in Treatment Regimen Change at Month 6 | Month 6 post-index date; retrospective data observed in this study for approximately 6 months | 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. |
| Percentage of Participants With Change in Treatment Regimen Change at Month 9 | Month 9 post-index date; retrospective data observed in this study for approximately 6 months | 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. |
| Percentage of Participants With Change in Treatment Regimen Change at Month 12 | Month 12 post-index date; retrospective data observed in this study for approximately 6 months | 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. |
| Time to Discontinuation of MHT | During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months | 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. |
| Time to Switching of MHT | During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months | 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. |
| Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type | Month 3 post-index; retrospective data observed in this study for approximately 6 months | 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. |
| Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type | Month 6 post-index; retrospective data observed in this study for approximately 6 months | 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. |
| Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type | Month 9 post-index; retrospective data observed in this study for approximately 6 months | 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. |
| Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type | Month 12 post-index; retrospective data observed in this study for approximately 6 months | 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. |
| Mean Treatment Adherence (%) | Index Date; retrospective data observed in this study for approximately 6 months | 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. |
Countries
South Korea
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Participants With MHT 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. | 1,036,294 |
| Total | 1,036,294 |
Baseline characteristics
| Characteristic | Participants With MHT | — |
|---|---|---|
| Age, Continuous | 52.53 Years STANDARD_DEVIATION 4.14 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1036294 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Mean Treatment Adherence (%)
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.
Time frame: Index Date; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With MHT | Mean Treatment Adherence (%) | Systemic MHT: ET | 37.3 Percentage of days | Standard Deviation 45.5 |
| Participants With MHT | Mean Treatment Adherence (%) | Systemic MHT: EPT | 22.4 Percentage of days | Standard Deviation 39 |
| Participants With MHT | Mean Treatment Adherence (%) | Systemic MHT: Tibolone | 35.5 Percentage of days | Standard Deviation 55 |
| Participants With MHT | Mean Treatment Adherence (%) | Local MHT: ET | 3.1 Percentage of days | Standard Deviation 27.2 |
Primary
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
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.
Time frame: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Vasomotor: 2016 | 358505 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Bone and joint: 2016 | 28208 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Genitourinary: 2016 | 80857 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Psychosomatic: 2016 | 1809 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Vasomotor: 2017 | 119084 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Bone and joint: 2017 | 8396 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Genitourinary: 2017 | 57812 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Psychosomatic: 2017 | 780 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Vasomotor: 2018 | 92169 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Bone and joint: 2018 | 6635 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Genitourinary: 2018 | 48640 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Psychosomatic: 2018 | 648 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Vasomotor: 2019 | 85728 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Bone and joint: 2019 | 6025 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Genitourinary: 2019 | 42798 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year | Psychosomatic: 2019 | 652 Participants |
Primary
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
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.
Time frame: Index Date; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Systemic MHT: Vasomotor symptoms | 649307 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Systemic MHT: Bone and joint symptoms | 83856 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Systemic MHT: Genitourinary symptoms | 44385 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Systemic MHT: Psychosomatic symptoms | 4951 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | ET: Vasomotor symptoms | 80044 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | ET: Bone and joint symptoms | 12479 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | ET: Genitourinary symptoms | 8087 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | ET: Psychosomatic symptoms | 710 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | EPT: Vasomotor symptoms | 287092 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | EPT: Bone and joint symptoms | 30659 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | EPT: Genitourinary symptoms | 16825 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | EPT: Psychosomatic symptoms | 2241 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Tibolone: Vasomotor symptoms | 283069 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Tibolone: Bone and joint symptoms | 40833 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Tibolone: Genitourinary symptoms | 19581 Participants |
| Participants With MHT | Number of Participants According to Each Type of Menopausal Symptoms Per MHT | Tibolone: Psychosomatic symptoms | 2021 Participants |
Primary
Number of Participants With MHT According to Type of Administration
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.
Time frame: Index Date; retrospective data observed in this study for approximately 6 months
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With MHT | Number of Participants With MHT According to Type of Administration | Systemic MHT (oral) | 693072 Participants |
| Participants With MHT | Number of Participants With MHT According to Type of Administration | Systemic MHT (transdermal) | 2960 Participants |
| Participants With MHT | Number of Participants With MHT According to Type of Administration | Local MHT (transvaginal) | 378764 Participants |
Primary
Number of Participants With Use of Any MHT According to Age Group
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.
Time frame: Index Date; retrospective data observed in this study for approximately 6 months
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With MHT | Number of Participants With Use of Any MHT According to Age Group | 40-44 Years | 39917 Participants |
| Participants With MHT | Number of Participants With Use of Any MHT According to Age Group | 45-49 Years | 199389 Participants |
| Participants With MHT | Number of Participants With Use of Any MHT According to Age Group | 50-54 Years | 425030 Participants |
| Participants With MHT | Number of Participants With Use of Any MHT According to Age Group | 55-59 Years | 371958 Participants |
Primary
Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year
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.
Time frame: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With MHT | Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year | 2016 | 786616 Participants |
| Participants With MHT | Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year | 2017 | 787425 Participants |
| Participants With MHT | Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year | 2018 | 791890 Participants |
| Participants With MHT | Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year | 2019 | 818749 Participants |
Primary
Number of Women With MHT Use Distributed Per Year
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.
Time frame: Index Date; retrospective data observed in this study for approximately 6 months
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With MHT | Number of Women With MHT Use Distributed Per Year | 2016 | 446702 Participants |
| Participants With MHT | Number of Women With MHT Use Distributed Per Year | 2017 | 473592 Participants |
| Participants With MHT | Number of Women With MHT Use Distributed Per Year | 2018 | 481568 Participants |
| Participants With MHT | Number of Women With MHT Use Distributed Per Year | 2019 | 494192 Participants |
Primary
Percentage of Participants With Change in Treatment Regimen Change at Month 12
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.
Time frame: Month 12 post-index date; retrospective data observed in this study for approximately 6 months
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 12 | Systemic ET | 3.0 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 12 | EPT | 7.0 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 12 | Tibolone | 9.4 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 12 | Local ET | 0.5 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 12 | No treatment provided | 80.1 Percentage of participants |
Primary
Percentage of Participants With Change in Treatment Regimen Change at Month 3
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.
Time frame: Month 3 post-index date; retrospective data observed in this study for approximately 6 months
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 3 | Systemic ET | 5.8 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 3 | EPT | 17.6 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 3 | Tibolone | 20.4 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 3 | Local ET | 4.1 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 3 | No treatment provided | 52.1 Percentage of participants |
Primary
Percentage of Participants With Change in Treatment Regimen Change at Month 6
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.
Time frame: Month 6 post-index date; retrospective data observed in this study for approximately 6 months
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 6 | Systemic ET | 4.3 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 6 | EPT | 11.0 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 6 | Tibolone | 14.0 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 6 | Local ET | 0.9 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 6 | No treatment provided | 69.8 Percentage of participants |
Primary
Percentage of Participants With Change in Treatment Regimen Change at Month 9
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.
Time frame: Month 9 post-index date; retrospective data observed in this study for approximately 6 months
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data were included and observed for evaluation in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 9 | Systemic ET | 3.5 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 9 | EPT | 8.5 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 9 | Tibolone | 11.1 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 9 | Local ET | 0.6 Percentage of participants |
| Participants With MHT | Percentage of Participants With Change in Treatment Regimen Change at Month 9 | No treatment provided | 76.3 Percentage of participants |
Primary
Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type
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.
Time frame: Month 12 post-index; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type | Systemic MHT: ET | 33.1 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type | Systemic MHT: EPT | 22.6 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type | Systemic MHT: Tibolone | 30.3 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type | Local MHT: ET | 0.2 Percentage of participants |
Primary
Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type
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.
Time frame: Month 3 post-index; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type | Systemic MHT: ET | 69.5 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type | Systemic MHT: EPT | 60.9 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type | Systemic MHT: Tibolone | 75.8 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type | Local MHT: ET | 11.8 Percentage of participants |
Primary
Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type
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.
Time frame: Month 6 post-index; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type | Systemic MHT: ET | 48.2 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type | Systemic MHT: EPT | 36.7 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type | Systemic MHT: Tibolone | 46.4 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type | Local MHT: ET | 1.1 Percentage of participants |
Primary
Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type
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.
Time frame: Month 9 post-index; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type | Systemic MHT: ET | 38.7 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type | Systemic MHT: EPT | 27.9 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type | Systemic MHT: Tibolone | 36.4 Percentage of participants |
| Participants With MHT | Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type | Local MHT: ET | 0.4 Percentage of participants |
Primary
Time to Discontinuation of MHT
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.
Time frame: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With MHT | Time to Discontinuation of MHT | Systemic MHT: ET | 14.4 Months | Standard Deviation 17.7 |
| Participants With MHT | Time to Discontinuation of MHT | Systemic MHT: EPT | 10.1 Months | Standard Deviation 13.7 |
| Participants With MHT | Time to Discontinuation of MHT | Systemic MHT: Tibolone | 13.4 Months | Standard Deviation 16.6 |
| Participants With MHT | Time to Discontinuation of MHT | Local MHT: ET | 2.4 Months | Standard Deviation 1.2 |
Primary
Time to Switching of MHT
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.
Time frame: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With MHT | Time to Switching of MHT | Systemic MHT: ET | 13.2 Months | Standard Deviation 15 |
| Participants With MHT | Time to Switching of MHT | Systemic MHT: EPT | 16.9 Months | Standard Deviation 15.5 |
| Participants With MHT | Time to Switching of MHT | Systemic MHT: Tibolone | 13.9 Months | Standard Deviation 14.7 |
| Participants With MHT | Time to Switching of MHT | Local MHT: ET | 7.1 Months | Standard Deviation 11.7 |