UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of hormone therapy and keishibukuryogan on blood pressure in perimenopausal and postmenopausal women
Title of the study (Brief title)	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	Masakazu Terauchi
Organization	Tokyo Medical and Dental University
Division name	Department of Obstetrics and Gynecology
Address	Yushima 1-5-45, Bunkyo, Tokyo
TEL	03-3813-6111
Email	teragyne@tmd.ac.jp

Public contact
Name of contact person	Masakazu Terauchi
Organization	Tokyo Medical and Dental University
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 01 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006934