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

Institute for Atherosclerosis Research, Russia

Status and phase: Completed; Phase 3

Conditions: Menopausal Syndrome; Atherosclerosis

Treatments: Drug: Placebo; Dietary Supplement: Karinat

Study type: Interventional

Funder types: Other

Identifiers

NCT01741974

IAR-KT-PERI

Details and patient eligibility

About

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.

Enrollment: 340 patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 2 patient groups, including a placebo group

Karinat

Active Comparator group

Description:

Karinat 500 mg tablet by mouth three times a day

Treatment:

Dietary Supplement: Karinat

Sugar pill

Placebo Comparator group

Description:

Placebo tablet 500 mg by mouth three times a day

Treatment:

Drug: Placebo