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OpenTrials
Completed

NCT Number: NCT06033521

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

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.

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Key information

Conditions

Menopause Bone Demineralization Bone Demineralization, Pathologic Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year–59 year

Sex eligibility

Female

Study type

Observational

Primary location

Pfizer South Korea

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Menopausal hormone therapy Intervention Type: Drug

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

Primary outcomes

  1. Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year

    Time frame: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months

    Menopausal symptoms: at least one inpatient or outpatient claim with any of diagnosis codes based on Korean standard classification of disease, 8th revision(KCD-8):Korean version of ICD-10(International statistical classification of diseases and related health problems,10th revision), per protocol. N95.1: Menopausal, female climacteric states; N95.2:Postmenopausal atrophic vaginitis; N95.3:States associated with artificial menopause; N95.8 Other specified menopausal, perimenopausal disorders; N95.9: Menopausal, perimenopausal disorder, unspecified; M80.0: Postmenopausal osteoporosis with pathological fracture;M81.0: Postmenopausal osteoporosis; M81.99:Osteoporosis, unspecified, site unspecified; Osteopenia; M85.99: Disorder of bone density, structure, unspecified, site unspecified; Osteopenia, mild; Osteopenia, moderate; Osteopenia, severe. One participant could have visited hospital for >=1 time for different menopausal symptom. Index date: date of first prescription for MHT.

  2. Number of Women With MHT Use Distributed Per Year

    Time frame: Index Date; retrospective data observed in this study for approximately 6 months

    Number of Women with MHT use distributed per year was reported in this outcome measure. One participant could have taken more than 1 type of MHT hence participants are not fully exclusive. Three types of MHT included ET (estrogen therapy), EPT (estrogen-progestin therapy), and tibolone. Index date was defined as the date of the first prescription for MHT.

  3. Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year

    Time frame: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months

    Menopausal symptoms included vasomotor, bone and joint, genitourinary and psychosomatic. One participant could have more than 1 type of menopausal symptoms. Index date was defined as the date of the first prescription for MHT.

  4. Number of Participants According to Each Type of Menopausal Symptoms Per MHT

    Time frame: Index Date; retrospective data observed in this study for approximately 6 months

    Menopausal symptoms included vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, psychosomatic symptoms for systemic, Estrogen Therapy (ET), Estrogen-Progestin Therapy (EPT) and Tibolone. One participant could have more than 1 type of menopausal symptoms and have received more than 1 type of therapy. Index date was defined as the date of the first prescription for MHT.

  5. Number of Participants With Use of Any MHT According to Age Group

    Time frame: Index Date; retrospective data observed in this study for approximately 6 months

    Number of participants with use of any MHT according to age group were reported in this outcome measure. Index date was defined as the date of the first prescription for MHT.

  6. Number of Participants With MHT According to Type of Administration

    Time frame: Index Date; retrospective data observed in this study for approximately 6 months

    Number of participants with MHT according to type of administration were reported in this outcome measure. Type of administration included systemic hormone therapy (HT) (oral), systemic HT (transdermal), local HT (transvaginal). One participant could have received more than 1 type of therapy. Index date was defined as the date of the first prescription for MHT.

  7. Percentage of Participants With Change in Treatment Regimen Change at Month 3

    Time frame: Month 3 post-index date; retrospective data observed in this study for approximately 6 months

    Percentage of participants with change in treatment regimen at Month 3 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.

  8. Percentage of Participants With Change in Treatment Regimen Change at Month 6

    Time frame: Month 6 post-index date; retrospective data observed in this study for approximately 6 months

    Percentage of participants with change in treatment regimen at Month 6 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.

  9. Percentage of Participants With Change in Treatment Regimen Change at Month 9

    Time frame: Month 9 post-index date; retrospective data observed in this study for approximately 6 months

    Percentage of participants with change in treatment regimen at Month 9 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.

  10. Percentage of Participants With Change in Treatment Regimen Change at Month 12

    Time frame: Month 12 post-index date; retrospective data observed in this study for approximately 6 months

    Percentage of participants with change in treatment regimen at Month 12 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.

  11. Time to Discontinuation of MHT

    Time frame: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months

    Time to discontinuation was defined as no subsequent prescriptions within 2 months of last prescription date. MHT included: Systemic MHT: ET, EPT, Tibolone and Local MHT: ET. Index date was defined as the date of the first prescription for MHT.

  12. Time to Switching of MHT

    Time frame: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months

    Time to switching of MHT was reported in this outcome measure. Participants who switched the treatment classes were included. MHT included: Systemic MHT: ET, EPT, Tibolone and Local MHT: ET. Index date was defined as the date of the first prescription for MHT.

  13. Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type

    Time frame: Month 3 post-index; retrospective data observed in this study for approximately 6 months

    Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.

  14. Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type

    Time frame: Month 6 post-index; retrospective data observed in this study for approximately 6 months

    Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.

  15. Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type

    Time frame: Month 9 post-index; retrospective data observed in this study for approximately 6 months

    Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.

  16. Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type

    Time frame: Month 12 post-index; retrospective data observed in this study for approximately 6 months

    Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.

  17. Mean Treatment Adherence (%)

    Time frame: Index Date; retrospective data observed in this study for approximately 6 months

    Treatment adherence was evaluated using medication possession ratio (MPR), calculated as the total number of days of medication supply divided by the number of days in the follow-up period. Data for this outcome is expressed in percentage. Index date was defined as the date of the first prescription for MHT.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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