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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06033521
Other study ID # B2311076
Secondary ID MHT RWD
Status Completed
Phase
First received
Last updated
Start date September 12, 2023
Est. completion date March 11, 2024

Study information

Verified date June 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 1
Est. completion date March 11, 2024
Est. primary completion date March 11, 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.

Study Design


Related Conditions & MeSH terms


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
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