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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute for Atherosclerosis Research, Russia
• Treatments: alpha-Tocopherol; Ascorbic Acid; Beta Carotene; Estrogens

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