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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06033521
Recruitment Status : Active, not recruiting
First Posted : September 13, 2023
Last Update Posted : March 29, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Menopause Bone Demineralization Drug: Menopausal hormone therapy Intervention Type: Drug

Study Design
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Study Type : Observational
Estimated Enrollment : 1774674 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns of Menopausal Hormone Therapy in South Korea: a Nationwide Cohort Study
Actual Study Start Date : September 12, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of menopausal symptoms [ Time Frame: 365 days ]
    Calculated as the number of women diagnosed with menopausal symptoms divided by the mid-year population of women (age 40-59 years).

  2. Prevalence of menopausal symptoms with Menopausal Hormone Therapy (MHT) [ Time Frame: 365 days ]
    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)

  3. Prevalence of menopausal symptom: bone and joint symptoms [ Time Frame: 365 days ]
    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.

  4. Prevalence of menopausal symptom: vasomotor symptoms [ Time Frame: 365 days ]
    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.

  5. Prevalence of menopausal symptom: genitourinary symptoms [ Time Frame: 365 days ]
    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.

  6. Prevalence of menopausal symptom: psychosomatic symptoms [ Time Frame: 365 days ]
    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.

  7. Trends in prevalence of MHT by treatment [ Time Frame: 90 days ]
    include estrogen therapy, estrogen-progestin therapy and tibolone

  8. Trends in prevalence of MHT by age [ Time Frame: 90 days ]
    include ages (40-44), (45-49), (50-54), and (55-59)

  9. Trends in prevalence of MHT by symptom [ Time Frame: 90 days ]
    include vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, and psychosomatic symptoms

  10. Trends in Prevalence of MHT by type of administration [ Time Frame: 90 days ]
    include systemic hormone therapies (oral), systemic hormone therapies (transdermal) and local hormone therapies (transvaginal)


Secondary Outcome Measures :
  1. Number of treatment regimens change of MHT across time [ Time Frame: 90 days ]
    Treatment switch and discontinuation patterns across time by measuring the number of different classes of MHT

  2. Time to switch and discontinuation of MHT [ Time Frame: 365 days ]
    The time to non-persistence events including switch and discontinuation

  3. Treatment Adherence using medication possession ratio (MPR) [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06033521


Locations
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Korea, Republic of
Pfizer South Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT06033521    
Other Study ID Numbers: B2311076
MHT RWD ( Other Identifier: Alias Study Number )
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Menopause
Bone Demineralization
Hormone Replacement Therapy
Additional relevant MeSH terms:
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Bone Demineralization, Pathologic
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs