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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Menopause; Bone Demineralization
• Intervention / Treatment: Drug: Menopausal hormone therapy Intervention Type: Drug

• Study Type: Observational
• Enrollment (Estimated): 1774674

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Pfizer South Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with menopausal hormone therapy; 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; 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

What is the study measuring?

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 type of administration	include systemic hormone therapies (oral), systemic hormone therapies (transdermal) and local hormone therapies (transvaginal)	90 days
Trends in prevalence of MHT by symptom	include vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, and psychosomatic symptoms	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Menopause; Hormone Replacement Therapy; Bone Demineralization
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Bone Demineralization, Pathologic; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: B2311076; MHT RWD (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No