Menopause Clinical Trial
Official title:
Treatment Patterns of Menopausal Hormone Therapy in South Korea: a Nationwide Cohort Study
Verified date | June 2024 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pfizer South Korea | Seoul |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04553029 -
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
|
||
Completed |
NCT03672513 -
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
|
N/A | |
Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04210583 -
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
Completed |
NCT05617287 -
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
|
N/A | |
Recruiting |
NCT05180266 -
Therapeutic Touch and Music in The Menopausal Period
|
N/A | |
Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
Completed |
NCT03363997 -
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
|
Phase 1 | |
Not yet recruiting |
NCT04724135 -
Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
|
||
Not yet recruiting |
NCT04728126 -
Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
|
||
Completed |
NCT02274571 -
Raising Insulin Sensitivity in Post Menopause
|
Early Phase 1 | |
Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
Recruiting |
NCT01488903 -
A Cohort Research of Genetic Susceptibility for Common Obesity in Women
|
N/A | |
Terminated |
NCT01633814 -
Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women
|
N/A | |
Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A |