MenopauseNCT06033521
A Study to Learn More About the Menopausal Hormone Therapies in Korea
An observational study of Menopause and Bone Demineralization, run by Pfizer at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 to 59 years, women only
- Conditions the study is for
- Menopause, Bone Demineralization
- What is being tested?
- Menopausal hormone therapy Intervention Type: Drug
- How many people
- 1,036,294 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Sep 2023to 11 Mar 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns of Menopausal Hormone Therapy in South Korea: a Nationwide Cohort Study
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.
Read more
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
- Being tested
- Menopausal hormone therapy Intervention Type: Drug
- Keywords
- Menopause, Bone Demineralization, Hormone Replacement Therapy
- Medical subject headings
- Bone Demineralization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menopausal hormone therapy Intervention Type: DrugDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Menopausal hormone therapy Intervention Type: Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Index Date; retrospective data observed in this study for approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start12 Sep 2023
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,036,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033521
- Sponsor's protocol ID
- B2311076
- Other IDs
- MHT RWD
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2023
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns of Menopausal Hormone Therapy in South Korea: a Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT06033521
- Acronym / sponsor ID
- B2311076
- Conditions
- Menopause, Bone Demineralization
- Keywords
- Menopause, Bone Demineralization, Hormone Replacement Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,036,294 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with menopausal hormone therapy | – | Drug: Menopausal hormone therapy Intervention Type: DrugSubjects 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 |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menopausal hormone therapy Intervention Type: DrugSubjects 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 | Women with menopausal hormone therapy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Bone Demineralization, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.