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Effect of hormone therapy on blood pressure in postmenopausal women with mild hypertension

Status Approved

First Submitted Date

2020/09/06
Registered Date

2020/09/22
Last Updated Date

2020/09/06

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1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005405
Unique Protocol ID	2010- 12-019-001
Public/Brief Title	Effect of menopausal hormone therapy on blood pressure in women with mild hypertension
Scientific Title	Effect of hormone therapy on blood pressure in postmenopausal women with mild hypertension
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2010- 12-019-001
Approval Date	2011-02-25
Institutional Review Board Name	Institutional Review Board, Samsung Medical Center
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Byung-Koo Yoon
Title	Professor
Telephone	+82-2-3410-3519
Affiliation	Samsung Medical Center
Address	81, Irwon-ro, Gangnam-gu, Seoul 06351
Contact Person for Public Queries
Name	Byung-Koo Yoon
Title	Professor
Telephone	+82-2-3410-3519
Affiliation	Samsung Medical Center
Address	81, Irwon-ro, Gangnam-gu, Seoul 06351
Contact Person for Updating Information
Name	Byung-Koo Yoon
Title	Professor
Telephone	+82-2-3410-3519
Affiliation	Samsung Medical Center
Address	81, Irwon-ro, Gangnam-gu, Seoul 06351

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2011-11-22 Actual
Target Number of Participant	120
Primary Completion Date
Study Completion Date
Name of Study	Samsung Medical Center
Recruitment Status	Active, not recruiting
Date of First Enrollment	2011-11-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Samsung Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Cardiovascular disease (CVD) including coronary heart disease (CHD) and stroke is the number 1 cause of death among women worldwide and hypertension belongs to the group of major risk factors of CVD with the strongest evidence for causation. Based on office blood pressure (BP), hypertension is defined as a systolic BP (SBP) of 140 mmHg or higher and/or diastolic BP (DBP) of 90 mmHg or higher. In the case of grade 1 hypertension with a low risk of CVD, lifestyle modifications including dietary alterations may be sufficient to delay or prevent the need for pharmacological intervention. Ambulatory BP monitoring (ABPM) can identify white-coat and masked hypertension, provides night-time readings, and is a stronger predictor of all-cause and cardiovascular mortality when compared with clinic BP. The loss of arterial elasticity leads to an increase in SBP and a decrease in DBP. Thus, arterial stiffness can precede hypertension and, importantly, be reversible in conjunction with lifestyle change or anti-hypertensive treatment. A sex difference in the prevalence of hypertension is apparent: such is lower in women aged 20 to 34 years than in men but increases steeply after menopause, leading to a cross-over after the age of 70 years. Further, the role of hypertension in death is greater in women than in men. These statistics strongly suggest a key role of ovarian hormones in hypertension. If initiated in early menopause, menopausal hormone therapy (MHT) using oral estrogen decreases the risk for CHD but has no impact on stroke. The effects of estrogen therapy on BP may differ by the route of administration probably via a first-pass hepatic effect. Conjugated equine estrogen (CEE), an oral estrogen, increases the clinic BP, whereas parenteral estrogen using a transdermal patch decreases ambulatory BP in postmenopausal women with both hypertension and normal BP. When compared with patch application, percutaneous estradiol gel (PEG), another parenteral preparation, has lower adverse skin effects and could provide higher estradiol serum values with less day-to-day variation. Medroxyprogesterone acetate (MPA) prescription is on the steep decline these days because of adverse impacts on estrogen in CHD and breast cancer. Thus, the search for a safe and effective progestogen for MHT is one of the top-priority matters in the field of menopause. The effects of progestogen on BP have been less well studied to date. Our group previously reported that micronized progesterone (MP4), combined with CEE, exerted favorable impacts on ambulatory BP in a prospective study. The purpose of this study was to evaluate the impact of MP4 added to PEG on ambulatory BP and arterial stiffness in postmenopausal Korean women with grade 1 hypertension.

Study Summary Information

Lay Summary

Cardiovascular disease (CVD) including coronary heart disease (CHD) and stroke is the number 1 cause of death among women worldwide and hypertension belongs to the group of major risk factors of CVD with the strongest evidence for causation. Based on office blood pressure (BP), hypertension is defined as a systolic BP (SBP) of 140 mmHg or higher and/or diastolic BP (DBP) of 90 mmHg or higher. In the case of grade 1 hypertension with a low risk of CVD, lifestyle modifications including dietary alterations may be sufficient to delay or prevent the need for pharmacological intervention.
Ambulatory BP monitoring (ABPM) can identify white-coat and masked hypertension, provides night-time readings, and is a stronger predictor of all-cause and cardiovascular mortality when compared with clinic BP. The loss of arterial elasticity leads to an increase in SBP and a decrease in DBP. Thus, arterial stiffness can precede hypertension and, importantly, be reversible in conjunction with lifestyle change or anti-hypertensive treatment.
A sex difference in the prevalence of hypertension is apparent: such is lower in women aged 20 to 34 years than in men but increases steeply after menopause, leading to a cross-over after the age of 70 years. Further, the role of hypertension in death is greater in women than in men. These statistics strongly suggest a key role of ovarian hormones in hypertension. If initiated in early menopause, menopausal hormone therapy (MHT) using oral estrogen decreases the risk for CHD but has no impact on stroke. The effects of estrogen therapy on BP may differ by the route of administration probably via a first-pass hepatic effect. Conjugated equine estrogen (CEE), an oral estrogen, increases the clinic BP, whereas parenteral estrogen using a transdermal patch decreases ambulatory BP in postmenopausal women with both hypertension and normal BP. When compared with patch application, percutaneous estradiol gel (PEG), another parenteral preparation, has lower adverse skin effects and could provide higher estradiol serum values with less day-to-day variation. Medroxyprogesterone acetate (MPA) prescription is on the steep decline these days because of adverse impacts on estrogen in CHD and breast cancer. Thus, the search for a safe and effective progestogen for MHT is one of the top-priority matters in the field of menopause. The effects of progestogen on BP have been less well studied to date. Our group previously reported that micronized progesterone (MP4), combined with CEE, exerted favorable impacts on ambulatory BP in a prospective study.
The purpose of this study was to evaluate the impact of MP4 added to PEG on ambulatory BP and arterial stiffness in postmenopausal Korean women with grade 1 hypertension.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	1. Drug 1) Estrogen: 17β-estradiol 1 mg (2 pumps)/day, 0.1% percutaneous gel (Estreva gel, Samil Pharm. Co., Seoul, Korea) 2) Progestogne: micronized progesterone 100 mg(1 capsule)/day, per os (Utrogestan, Besins Healthcare, Brussel, Belgium) 2. Intervention arm 1) Placebo 2) Estrrogen therapy 3) Estrrogen + progestogen therapy
Number of Arms	3
Arm 1	Arm Label Placebo
	Target Number of Participant 40
	Arm Type Placebo comparator
	Arm Description Estrogen, placebo; 2 pumps/day Progestogen. placebo; 1 capsule/day
Arm 2	Arm Label Estrorogen therapy
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description Estrogen, active; 2 pumps/day Progestogen, placebo; 1 capsule/day
Arm 3	Arm Label Estrrogen + progestogen therapy
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description Estrogen, active; 2 pumps/day Progestogen, active; 1 capsule/day

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N95.8)Other specified menopausal and perimenopausal disorders Hormone Replacement Therapy; Estrogens; Progesterone; Hypertension; Vascular Stiffness
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 45Year~80Year
	Description Postmenopausal women (duration of amenorrhea: 12 months or longer or serum follicle-stimulating hormone value: 30 mIU/mL or higher) Grade 1 hypertension: according to clinic BP measured at the arm, systolic BP of 140 to 159 mmHg or diastolic BP of 90 to 99 mmHg. Women with uncontrolled hypertension using antihypertensive medication for at least six months Women whose BP was controlled but who wanted to hold their BP medication were included if the BP rebounded only to grade 1 after two weeks of washout.
Exclusion Criteria	Symptomatic coronary heart disease or stroke Current or recent (within one year prior to enrollment) smoking Uncontrolled diabetes mellitus (glycated hemoglobin > 8%) Secondary hypertension Hypertension with serious target organ injury suspected Current or recent (within three months before the time of the study entry) MHT use Contraindications for MHT including acutely impaired liver function, breast cancer, and venous thrombosis.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Ambulatory blood pressure
Timepoint	after 12-week treatment
Secondary Outcome(s) 1
Outcome	Arterial stiffness
Timepoint	after 12-week treatment

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2022. 6
Way of Sharing	Available on Request (bkyoon@skku.edu)

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