UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005868 |
|---|---|
| Receipt number | R000006934 |
| Scientific Title | Effects of hormone therapy and keishibukuryogan on blood pressure in perimenopausal and postmenopausal women |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2018/01/04 14:47:29 |
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Basic information
Public title
Effects of hormone therapy and keishibukuryogan on blood pressure in perimenopausal and postmenopausal women
Acronym
Effects of hormone therapy and keishibukuryogan on blood pressure in perimenopausal and postmenopausal women
Scientific Title
Effects of hormone therapy and keishibukuryogan on blood pressure in perimenopausal and postmenopausal women
Scientific Title:Acronym
Effects of hormone therapy and keishibukuryogan on blood pressure in perimenopausal and postmenopausal women
Region
| Japan |
Condition
Condition
climacteric syndrome
hypertension
Classification by specialty
| Cardiology | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of hormone therapy and keishibukuryogan on women who are bothered by menopausal symptoms and have high blood pressure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
menopausal symptoms
blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
4-week treatment with micronized estradiol 1 mg/day
Interventions/Control_2
4-week treatment with keishibukuryogan 7.5 g/day
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
| 40 | years-old | < |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
women who are bothered by menopausal symptoms and have hypertension or high-normal blood pressure
Key exclusion criteria
(1) past history of breast cancer, endometrial cancer, coronary heart diseases, stroke, or vascular thromboembolism (2) current use of antihypertensives (3) current use of hormone therapy or Kampo medicines (4) past history of allergy or liver dysfunction by the use of estrogens, progestins, or Kampo medicines
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-3813-6111
teragyne@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-3813-6111
Homepage URL
m.terauchi.gyne@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006934
