Back to resultsStudy of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women (PEARS)
Primary Purpose
Menopausal Syndrome, Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Karinat
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Menopausal Syndrome focused on measuring perimenopause, phytoestrogen, atherosclerosis, intima-media thickness
Eligibility Criteria
Inclusion Criteria:
- Perimenopausal women aged 45 to 60 years with intact womb and ovaries
- The absence of menstruations between 6 to 24 months
- Last menstruation after the age of 40 years
- Follicle-stimulating hormone (FSH) blood level ≥ 35 ng/ml
- Mammography without nodal form of mastopathy or breast cancer signs
- Absence of hypolipidemic therapy or HRT (hormone replacement therapy) during 6 months before the inclusion
Exclusion Criteria:
- Administration of lipid-lowering drugs, and/or HRT, and/or phytoestrogens during 6 month before inclusion
- Personal history or diagnostic of following diseases:
nodal form of mastopathy or breast cancer any cancer except non-melanoma skin cancer stroke or myocardial infarction chronic renal failure II-III chronic hepatic failure II-III liver cirrhosis chronic heart failure IIa-III exacerbation of chronic stomach or duodenal ulcer obesity (BMI >30 kg/m2) alcohol abuse uncontrolled arterial hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 90 mmHg) current cigarette smoking (>10 cigarettes a day) diabetes mellitus deep vein thrombosis or pulmonary embolism
- Individual intolerance of Karinat or major side effects
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Karinat
Sugar pill
Arm Description
Karinat 500 mg tablet by mouth three times a day
Placebo tablet 500 mg by mouth three times a day
Outcomes
Primary Outcome Measures
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
Secondary Outcome Measures
Measure of serum atherogenicity
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Full Information
NCT ID
NCT01741974
First Posted
December 2, 2012
Last Updated
December 4, 2012
Sponsor
Institute for Atherosclerosis Research, Russia
1. Study Identification
Unique Protocol Identification Number
NCT01741974
Brief Title
Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Acronym
PEARS
Official Title
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Atherosclerosis Research, Russia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopausal Syndrome, Atherosclerosis
Keywords
perimenopause, phytoestrogen, atherosclerosis, intima-media thickness
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
340 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Karinat
Arm Type
Active Comparator
Arm Description
Karinat 500 mg tablet by mouth three times a day
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo tablet 500 mg by mouth three times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Karinat
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill manufactured to mimic Karinat 500 mg tablet
Primary Outcome Measure Information:
Title
B-mode ultrasound of carotid arteries
Description
Variation of intima-media thickness of common carotid arteries
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Measure of serum atherogenicity
Description
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Time Frame
up to 3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Perimenopausal women aged 45 to 60 years with intact womb and ovaries
The absence of menstruations between 6 to 24 months
Last menstruation after the age of 40 years
Follicle-stimulating hormone (FSH) blood level ≥ 35 ng/ml
Mammography without nodal form of mastopathy or breast cancer signs
Absence of hypolipidemic therapy or HRT (hormone replacement therapy) during 6 months before the inclusion
Exclusion Criteria:
Administration of lipid-lowering drugs, and/or HRT, and/or phytoestrogens during 6 month before inclusion
Personal history or diagnostic of following diseases:
nodal form of mastopathy or breast cancer any cancer except non-melanoma skin cancer stroke or myocardial infarction chronic renal failure II-III chronic hepatic failure II-III liver cirrhosis chronic heart failure IIa-III exacerbation of chronic stomach or duodenal ulcer obesity (BMI >30 kg/m2) alcohol abuse uncontrolled arterial hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 90 mmHg) current cigarette smoking (>10 cigarettes a day) diabetes mellitus deep vein thrombosis or pulmonary embolism
Individual intolerance of Karinat or major side effects
12. IPD Sharing Statement
Learn more about this trial
Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
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