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

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

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Menopausal Syndrome
• Intervention / Treatment: Dietary supplement: Karinat; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Karinat; Karinat 500 mg tablet by mouth three times a day	Dietary supplement: Karinat
PLACEBO_COMPARATOR: Sugar pill; Placebo tablet 500 mg by mouth three times a day	Drug: Placebo; Sugar pill manufactured to mimic Karinat 500 mg tablet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute for Atherosclerosis Research, Russia

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: December 2, 2012
• First Submitted That Met QC Criteria: December 2, 2012
• First Posted (ESTIMATE): December 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: atherosclerosis; phytoestrogen; perimenopause; intima-media thickness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: IAR-KT-PERI