N/A N=1,036,294

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

Menopause · Bone Demineralization

Bottom Line

View on ClinicalTrials.gov: NCT06033521 ↗

Enrolled (actual)

1,036,294

Serious AEs

—

Results posted

Apr 2025

Primary outcome: Primary: Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year — 786616; 787425; 791890; 818749 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Menopausal hormone therapy Intervention Type: Drug (Drug)
Age: Adult · 40+ yrs
Sex: Female
Sponsor: Pfizer
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year	786616; 787425; 791890; 818749	—
PRIMARY Number of Women With MHT Use Distributed Per Year	446702; 473592; 481568; 494192	—
PRIMARY Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year	358505; 28208; 80857; 1809; 119084; 8396	—
PRIMARY Number of Participants According to Each Type of Menopausal Symptoms Per MHT	649307; 83856; 44385; 4951; 80044; 12479	—
PRIMARY Number of Participants With Use of Any MHT According to Age Group	39917; 199389; 425030; 371958	—
PRIMARY Number of Participants With MHT According to Type of Administration	693072; 2960; 378764	—
PRIMARY Percentage of Participants With Change in Treatment Regimen Change at Month 3	5.8; 17.6; 20.4; 4.1; 52.1	—
PRIMARY Percentage of Participants With Change in Treatment Regimen Change at Month 6	4.3; 11.0; 14.0; 0.9; 69.8	—
PRIMARY Percentage of Participants With Change in Treatment Regimen Change at Month 9	3.5; 8.5; 11.1; 0.6; 76.3	—
PRIMARY Percentage of Participants With Change in Treatment Regimen Change at Month 12	3.0; 7.0; 9.4; 0.5; 80.1	—
PRIMARY Time to Discontinuation of MHT	14.4; 10.1; 13.4; 2.4	—
PRIMARY Time to Switching of MHT	13.2; 16.9; 13.9; 7.1	—
PRIMARY Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type	69.5; 60.9; 75.8; 11.8	—
PRIMARY Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type	48.2; 36.7; 46.4; 1.1	—
PRIMARY Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type	38.7; 27.9; 36.4; 0.4	—
PRIMARY Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type	33.1; 22.6; 30.3; 0.2	—
PRIMARY Mean Treatment Adherence (%)	37.3; 22.4; 35.5; 3.1	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06033521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.