Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women

Conditions
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Menopausal Syndrome, Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: Karinat
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Karinat<br>Karinat 500 mg tablet by mouth three times a day | Dietary Supplement: Karinat<br> <br> |
| Placebo Comparator: Sugar pill<br>Placebo tablet 500 mg by mouth three times a day | Drug: Placebo<br>* Sugar pill manufactured to mimic Karinat 500 mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B-mode ultrasound of carotid arteries | Variation of intima-media thickness of common carotid arteries | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of serum atherogenicity | Change of the ability of serum to induce cholesterol accumulation in cultured cells | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perimenopause, phytoestrogen, atherosclerosis, intima-media thickness