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Completed

NCT Number: NCT01741974

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.

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Key information

Conditions

Menopausal Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Karinat

Dietary Supplement

Placebo

Drug

Sugar pill manufactured to mimic Karinat 500 mg tablet

Primary outcomes

  1. B-mode ultrasound of carotid arteries

    Time frame: up to 3 years

    Variation of intima-media thickness of common carotid arteries

Secondary outcomes

  1. Measure of serum atherogenicity

    Time frame: up to 3 years

    Change of the ability of serum to induce cholesterol accumulation in cultured cells

Sponsors and collaborators

Lead sponsor

Institute for Atherosclerosis Research, Russia

Other

Registry information

Official study title

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

Acronym: PEARS

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2012
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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