CompletedPhase 3

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

340 participantsStarted 2005-10

Plain-language 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.

Who can participate

Age range

40 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

B-mode ultrasound of carotid arteries

Timeframe: up to 3 years

Trial details

NCT IDNCT01741974

SponsorInstitute for Atherosclerosis Research, Russia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Menopausal Syndrome trials