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

I

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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