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

Pfizer

Status: Completed

Conditions: Menopause; Bone Demineralization

Treatments: Drug: Menopausal hormone therapy Intervention Type: Drug

Study type: Observational

Funder types: Industry

Identifiers

NCT06033521

MHT RWD (Other Identifier)

B2311076

Details and patient eligibility

About

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.

Enrollment: 1,036,294 patients

Sex: Female

Ages: 40 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,036,294 participants in 1 patient group

Women with menopausal hormone therapy

Description:

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

Treatment:

Drug: Menopausal hormone therapy Intervention Type: Drug