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

NCT06033521 | Completed Results FDA Drug

• 2 other identifiers: B2311076MHT RWD
• Study Type: observational
• Target: 1,036,294
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Bone Demineralization

Keywords

Menopause; Bone Demineralization; Hormone Replacement Therapy

Outcome Measures

Primary Outcomes (17)

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

  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.

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

• Number of Women With MHT Use Distributed Per Year

  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.

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

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

  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.

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

• Number of Participants According to Each Type of Menopausal Symptoms Per MHT

  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.

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

• Number of Participants With Use of Any MHT According to Age Group

  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.

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

• Number of Participants With MHT According to Type of Administration

  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.

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

• Percentage of Participants With Change in Treatment Regimen Change at Month 3

  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.

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

• Percentage of Participants With Change in Treatment Regimen Change at Month 6

  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.

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

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

  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.

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

• Percentage of Participants With Change in Treatment Regimen Change at Month 12

  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.

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

• Time to Discontinuation of MHT

  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.

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

• Time to Switching of MHT

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

• Mean Treatment Adherence (%)

  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.

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

Study Arms (1)

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

Interventions

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

Women with menopausal hormone therapy

Eligibility Criteria

• Age: 40 Years - 59 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer South Korea

Seoul, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bone Demineralization, Pathologic

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: September 12, 2023
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)