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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005868
Receipt No. 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

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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 Obsterics 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
Email 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
Email m.terauchi.gyne@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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