Clinical trial NCT06033521: A Study to Learn More About the Menopausal Hormone Therapies in Korea
Official title: Treatment Patterns of Menopausal Hormone Therapy in South Korea: a Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Bone Demineralization
Keywords: Menopause
Bone Demineralization
Hormone Replacement Therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 1036294
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year
timeFrame: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months
measure: Number of Women With MHT Use Distributed Per Year
timeFrame: Index Date; retrospective data observed in this study for approximately 6 months
measure: Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
timeFrame: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months
measure: Number of Participants According to Each Type of Menopausal Symptoms Per MHT
timeFrame: Index Date; retrospective data observed in this study for approximately 6 months
measure: Number of Participants With Use of Any MHT According to Age Group
timeFrame: Index Date; retrospective data observed in this study for approximately 6 months
measure: Number of Participants With MHT According to Type of Administration
timeFrame: Index Date; retrospective data observed in this study for approximately 6 months
measure: Percentage of Participants With Change in Treatment Regimen Change at Month 3
timeFrame: Month 3 post-index date; retrospective data observed in this study for approximately 6 months
measure: Percentage of Participants With Change in Treatment Regimen Change at Month 6
timeFrame: Month 6 post-index date; retrospective data observed in this study for approximately 6 months
measure: Percentage of Participants With Change in Treatment Regimen Change at Month 9
timeFrame: Month 9 post-index date; retrospective data observed in this study for approximately 6 months
measure: Percentage of Participants With Change in Treatment Regimen Change at Month 12
timeFrame: Month 12 post-index date; retrospective data observed in this study for approximately 6 months
measure: Time to Discontinuation of MHT
timeFrame: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months
measure: Time to Switching of MHT
timeFrame: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months
measure: Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type
timeFrame: Month 3 post-index; retrospective data observed in this study for approximately 6 months
measure: Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type
timeFrame: Month 6 post-index; retrospective data observed in this study for approximately 6 months
measure: Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type
timeFrame: Month 9 post-index; retrospective data observed in this study for approximately 6 months
measure: Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type
timeFrame: Month 12 post-index; retrospective data observed in this study for approximately 6 months
measure: Mean Treatment Adherence (%)
timeFrame: Index Date; retrospective data observed in this study for approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer South Korea
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: