Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
NCT ID: NCT01741974
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
340 participants
INTERVENTIONAL
2005-10-31
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Karinat
Karinat 500 mg tablet by mouth three times a day
Karinat
Sugar pill
Placebo tablet 500 mg by mouth three times a day
Placebo
Sugar pill manufactured to mimic Karinat 500 mg tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Karinat
Placebo
Sugar pill manufactured to mimic Karinat 500 mg tablet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
55 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute for Atherosclerosis Research, Russia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IAR-KT-PERI
Identifier Type: -
Identifier Source: org_study_id