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

Phase 3

Completed

• Conditions: Menopausal Syndrome; Atherosclerosis
• Interventions: Dietary Supplement: Karinat; Drug: Placebo

• Registration Number: NCT01741974
• Lead Sponsor: Institute for Atherosclerosis Research, Russia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Status Verified: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-02
• Last Update Submitted: 2012-12-04
• Study First Posted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Karinat	Karinat	Karinat 500 mg tablet by mouth three times a day
Sugar pill	Placebo	Placebo tablet 500 mg by mouth three times a day

Primary Outcome Measures

Name	Time	Method
B-mode ultrasound of carotid arteries	up to 3 years	Variation of intima-media thickness of common carotid arteries

Secondary Outcome Measures

Name	Time	Method
Measure of serum atherogenicity	up to 3 years	Change of the ability of serum to induce cholesterol accumulation in cultured cells