Study of Anti-atherosclerotic and Estrogen-like Activity... | NCT01741974

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

NCT01741974

Sponsor

Institute for Atherosclerosis Research, Russia

Status

Completed

Last Update Posted

Dec 6, 2012Estimated

Enrollment

340Actual

Phase

Phase 3

Conditions

Menopausal Syndrome
Atherosclerosis

Interventions

Karinat
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Jun 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Dec 2, 2012

First Submission Date that Met QC Criteria

Dec 2, 2012

First Posted Date

Dec 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2012

Last Update Posted Date

Dec 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Karinat	Active Comparator	Karinat 500 mg tablet by mouth three times a day	Dietary Supplement: Karinat
Sugar pill	Placebo Comparator	Placebo tablet 500 mg by mouth three times a day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Karinat	Dietary Supplement		Karinat
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
B-mode ultrasound of carotid arteries	Variation of intima-media thickness of common carotid arteries	up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Measure of serum atherogenicity	Change of the ability of serum to induce cholesterol accumulation in cultured cells	up to 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Oct 8, 2020
Reset	Oct 30, 2020

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 8, 2020			Oct 30, 2020

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided