A Study to Learn More About the Menopausal Hormone Therapies in Korea

Study Overview
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Brief Summary
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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.

Official Title
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Treatment Patterns of Menopausal Hormone Therapy in South Korea: a Nationwide Cohort Study

Conditions
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Menopause, Bone Demineralization

Intervention / Treatment
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* Drug: Menopausal hormone therapy Intervention Type: Drug


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with menopausal hormone therapy<br>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 | Drug: Menopausal hormone therapy Intervention Type: Drug<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of menopausal symptoms | Calculated as the number of women diagnosed with menopausal symptoms divided by the mid-year population of women (age 40-59 years). | 365 days | 
| Prevalence of menopausal symptoms with Menopausal Hormone Therapy (MHT) | Calculated as the number of women diagnosed with menopausal symptoms and prescribed with MHT divided by the mid-year population of women (ages 40 - 59 years) | 365 days | 
| Prevalence of menopausal symptom: bone and joint symptoms | The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT. | 365 days | 
| Prevalence of menopausal symptom: vasomotor symptoms | The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT. | 365 days | 
| Prevalence of menopausal symptom: genitourinary symptoms | The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT. | 365 days | 
| Prevalence of menopausal symptom: psychosomatic symptoms | The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT. | 365 days | 
| Trends in prevalence of MHT by treatment | include estrogen therapy, estrogen-progestin therapy and tibolone | 90 days | 
| Trends in prevalence of MHT by age | include ages (40-44), (45-49), (50-54), and (55-59) | 90 days | 
| Trends in prevalence of MHT by symptom | include vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, and psychosomatic symptoms | 90 days | 
| Trends in Prevalence of MHT by type of administration | include systemic hormone therapies (oral), systemic hormone therapies (transdermal) and local hormone therapies (transvaginal) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment regimens change of MHT across time | Treatment switch and discontinuation patterns across time by measuring the number of different classes of MHT | 90 days | 
| Time to switch and discontinuation of MHT | The time to non-persistence events including switch and discontinuation | 365 days | 
| Treatment Adherence using medication possession ratio (MPR) |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Bone Demineralization, Hormone Replacement Therapy