Trial | NCT01741974  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    340
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 Started
Oct 31
2005
Primary Completion
Jun 30
2012
Study Completion
Oct 31
2012
Last Update
Dec 06
2012
Estimate

Dietary Supplement Karinat

Drug Placebo

Sugar pill manufactured to mimic Karinat 500 mg tablet

Karinat Active Comparator

Karinat 500 mg tablet by mouth three times a day

Sugar pill Placebo Comparator

Placebo tablet 500 mg by mouth three times a day

Criteria 

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
No Results Posted