UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045133 |
|---|---|
| Receipt number | R000051513 |
| Scientific Title | Japan Society for Menopause and Women's Health Hormone Replacement Therapy Database Project - JHDP - - Registry of hormone replacement therapy and long-term follow-up study - |
| Date of disclosure of the study information | 2021/08/12 |
| Last modified on | 2021/08/12 12:23:00 |
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Basic information
Public title
New User Registry of Hormone Replacement Therapy and Long-Term Follow-up Study in Japan
Acronym
JHDP
Scientific Title
Japan Society for Menopause and Women's Health Hormone Replacement Therapy Database Project - JHDP -
- Registry of hormone replacement therapy and long-term follow-up study -
Scientific Title:Acronym
JHDP
Region
| Japan |
Condition
Condition
postmenopausal disorders
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will register women who newly start HRT at medical institutions to which members of the Japanese Society for Menopause and Women's Health belong, and investigate the course of HRT prescription and health events for 5 years after registration, regardless of whether HRT is continued. The primary objective of this study is to verify the actual status, efficacy, safety, and impact on QOL of HRT in Japan from real-world data.
In addition, we will construct a nationwide HRT registry database that can be used as a data source for future drug-specific safety studies and clinical development studies of new drugs. The second objective is to contribute to society as our society by constructing such a new database.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
cancer incidence and mortality (breast cancer, ovarian cancer, endometrial cancer, cervical cancer, colorectal cancer, etc.) (6 months, 1 year, 2 years, 3 years, 4 years, 5 years after study start)
Key secondary outcomes
HRT regimen
Patient quality of life
Cardiovascular disease incidence and mortality (myocardial infarction, angina pectoris, subarachnoid hemorrhage, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism)
Changes in menopausal symptoms according to the Japanese Society of Obstetrics and Gynecology Menopausal Symptom Assessment Table
Changes in bone mineral density and incidence of pathological fracture
Changes in obesity, body weight, lipid profile, and blood pressure levels
Adverse events (abnormal uterine bleeding, breast distension, headache, abnormal laboratory values, others)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who are newly starting hormone replacement therapy for the prevention or treatment of symptoms or diseases associated with estrogen deficiency.
Women who are able to give written consent to cooperate in the long-term follow-up survey
Women who are able to participate in the follow-up survey via smartphone.
Key exclusion criteria
Women for whom hormone replacement therapy is contraindicated
- Severe active liver disease
- Current breast cancer and history of breast cancer
- Current endometrial cancer, low-grade endometrial stromal sarcoma
- Unexplained abnormal uterine bleeding
- Suspected pregnancy
- Acute thrombophlebitis or venous thromboembolism and history thereof
- History of myocardial infarction and atherosclerotic lesions in coronary arteries
- History of stroke
Women who have received hormone replacement therapy by the time of enrollment
Target sample size
60000
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Takamatsu |
Organization
The Japan Society for Menopause and Women's Health
Division name
Subcommittee on Hormone Replacement Therapy Registration and Research
Zip code
103-0027
Address
Congres Inc., Onward Park Building, 3-10-5, Nihonbashi, Chuuou-ku, Tokyo, 103-0027
TEL
03-3510-3748
ktakamatsu@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Mieko |
| Middle name | |
| Last name | Nobusawa |
Organization
The Japan Society for Menopause and Women's Health
Division name
secretariat
Zip code
103-0027
Address
Congres Inc., Onward Park Building, 3-10-5, Nihonbashi, Chuuou-ku, Tokyo, 103-0027
TEL
03-3510-3748
Homepage URL
jmwh@congre.co.jp
Sponsor or person
Institute
The Japan Society for Menopause and Women's Health
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for Menopause and Women's Health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Japan Society for Menopause and Women's Health
Address
Congres Inc., Onward Park Building, 3-10-5, Nihonbashi, Chuuou-ku, Tokyo, 103-0027
Tel
03-3510-3748
jmwh@congre.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective cohort study
Subjects: Women who newly started HRT after August 2021 and agreed in writing to participate in the long-term follow-up survey at 346 facilities nationwide will be registered in the hormone replacement therapy database of the Japanese Society of Women's Medicine. The S-Registry System installed at Gunma University will be used for registration.
Endpoints: QOL, life expectancy, efficacy (menopausal symptoms, bone mass, fracture, etc.), safety (breast cancer, ovarian cancer, uterine cancer, stroke, venous thromboembolism, etc.)
Planned study period (Phase I): August 2021~October 2030
Enrollment period: August 2021~October 2025
Follow-up period: 5 years from the start of enrollment of each patient (regardless of whether HRT is continued or completed)
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051513
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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