Menopausal SyndromePhase 3PEARSNCT01741974
Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
A Phase 3 study testing Karinat in people with Menopausal Syndrome and Atherosclerosis, run by Institute for Atherosclerosis Research, Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Syndrome, Atherosclerosis
- What is being tested?
- Karinat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
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.
- Conditions
- Menopausal Syndrome, Atherosclerosis
- Being tested
- Karinat, Placebo
- Keywords
- perimenopause, phytoestrogen, atherosclerosis, intima-media thickness
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarinatDietary supplement
PlaceboDrug
Sugar pill manufactured to mimic Karinat 500 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Karinat | Active comparator | Karinat 500 mg tablet by mouth three times a day Receives: Dietary Supplement: Karinat |
| Sugar pill | Placebo comparator | Placebo tablet 500 mg by mouth three times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
Measured: up to 3 years
Secondary outcomes (1)
Measure of serum atherogenicity
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2005
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Atherosclerosis Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741974
- Sponsor's protocol ID
- IAR-KT-PERI
- Acronym
- PEARS
- Status last verified
- Jan 2012
- First submitted
- 2 Dec 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT01741974
- Acronym / sponsor ID
- PEARS / IAR-KT-PERI
- Conditions
- Menopausal Syndrome, Atherosclerosis
- Keywords
- perimenopause, phytoestrogen, atherosclerosis, intima-media thickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Institute for Atherosclerosis Research, RussiaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Karinat | Active comparator | Dietary Supplement: KarinatKarinat 500 mg tablet by mouth three times a day |
| Sugar pill | Placebo comparator | Drug: PlaceboPlacebo tablet 500 mg by mouth three times a day |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Karinat | Dietary supplement | Karinat |
| PlaceboSugar pill manufactured to mimic Karinat 500 mg tablet | Drug | Sugar pill |
Primary outcome
B-mode ultrasound of carotid arteries
Time frame: up to 3 years
Variation of intima-media thickness of common carotid arteries
1 secondary outcome
Measure of serum atherogenicity
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Karinat in people with Menopausal Syndrome and Atherosclerosis, run by Institute for Atherosclerosis Research, Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-mode ultrasound of carotid arteries (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.