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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06033521
• Other study ID #: B2311076
• Secondary ID: MHT RWD
• Status: Active, not recruiting
• Start date: September 12, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1774674
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Demineralization
• Menopause

Intervention

Drug:
• Menopausal 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

Locations

Country	Name	City	State
Korea, Republic of	Pfizer South Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Trends in prevalence of MHT by treatment	include estrogen therapy, estrogen-progestin therapy and tibolone	90 days
Primary	Trends in prevalence of MHT by age	include ages (40-44), (45-49), (50-54), and (55-59)	90 days
Primary	Trends in prevalence of MHT by symptom	include vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, and psychosomatic symptoms	90 days
Primary	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	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
Secondary	Time to switch and discontinuation of MHT	The time to non-persistence events including switch and discontinuation	365 days
Secondary	Treatment Adherence using medication possession ratio (MPR)		90 days

External Links

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