MenopausePhase 4OMEGASINCT02195609
Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
A Phase 4 study testing Omega-3 and Soy Isoflavones in people with Menopause and Hot Flashes, run by Instituto Palacios at 1 site in Spain.
Trial summary
This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women treated for 4 months with Omega-3 vs Soy Isoflavones. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- Omega-3 and Soy Isoflavones
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Nov 2015
- Phase
- Phase 4
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory and can complete all study procedures, which are able to read, understand and sign an informed consent and willing to come to the center for study visits.
- Postmenopausal (≥ 1 year of amenorrhea) or 6 months or more of amenorrhea with follicle stimulating hormone (FSH) ≥ 40 IU / L.
- BMI ≥ 18 kg/m2 and ≤ 30 kg/m2
- Flushing of moderate to severe intensity.
Who cannot join
- Women with surgical menopause.
- Treatment with hormone replacement therapy (HRT) in the 3 months prior to inclusion
- Uterine bleeding after menopause with undetermined cause in the 12 months prior to screening.
- Presence or history of malignancy in the past 5 years.
- Malabsorption syndrome.
- Hype or uncontrolled hypothyroidism.
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- Dyslipidemia (LDL-cholesterol> 189 mg / dl or medical criteria) requiring an specific treatment of proven effectiveness.
- Chronic renal disease.
- Uncontrolled or untreated hypertension.
- Treatment with isoflavones, tibolone, Selective Estrogen Receptors Moderators (SERM´s) in the past 3 months prior to the testing selection period.
- Hormonal treatment with androgens, estrogens, progestins, alone or combined oral, transdermal, vaginal (including promestriene) or implant, in the last 3 months prior to testing selection period.
- Patients who receive or require treatment with antidepressants or anticonvulsants
- Patients with mental illness.
- History of noncompliance with taking medication.
- Suspected or abuse of alcohol or other drugs during the 12 months preceding the selection.
- Use of any experimental drug or device within 30 days prior to the selection.
- Any other condition or finding that a judgment of the investigator may jeopardise the tral conduct according to the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Open Label Study to Evaluate the Effect of (Omega-3) EPA + Docosahexaenoic Acid (DHA) vs Soy Isoflavones in 100 Postmenopausal Women Between 45-65 Years With Moderate to Severe Vasomotor Symptoms.
This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women treated for 4 months with Omega-3 vs Soy Isoflavones.
Read the detailed description
This is a non-inferiority study of Omega 3 versus Soy Isoflavones, being each patient its own control from the baseline.
In order to determine the difference observed in the evolution of intensity, frequency and the total number of hot flashes in 4 months in patients treated with Omega-3 vs Soy Isoflavones, is planned to include at least 100 patients, 50 per treatment arm.
It si estimated a standar deviation of 0.5%, and a 10% lost follow-up rate.
- Conditions
- Menopause, Hot Flashes
- Being tested
- Omega-3, Soy Isoflavones
- Keywords
- Vasomotor Symptoms Associated With Menopause, Menopause, Hot Flashes, Postmenopausal Women
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called Om3gafort
600 mg oral twice a day
Soy IsoflavonesDietary supplement
Also called Flavia
54.4 mg oral twice a day
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Other | 600 mg (EPA, DHA and Omega-3) twice a day Receives: Dietary Supplement: Omega-3 |
| Soy Isoflavones | Other | 54.4mg oral twice a day Receives: Dietary Supplement: Soy Isoflavones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the changes in vasomotor symptoms.
To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .
Measured: 0 to 4 months
Secondary outcomes (9)
Cardiovascular risk factors
serum cholesterol
Measured: 0 and 4 months
Satisfaction with treatment
Treatment Satisfaction Questionnaire for Medication
Measured: at month 1 and 4
Mood status
Hospital Anxiety and Depression Scale (HADS)
Measured: 0, 1 and 4 months
General health status
General health status by Short-Form 36 (SF-36) questionnaire
Measured: months 0, 1 and 4
Rating memory status
Alteration of the memory test (T@M)
Measured: at 0, 1 and 4 months
Cardiovascular risk factors
serum triglycerides
Measured: 0 amd 4 months
Cardiovascular risk factors
Blood pressure
Measured: 0, 1 and 4 months
Cardiovascular risk factors
Body mass index
Measured: 0, 1 and 4 months
Cardiovascular risk factors
abdominal circumference
Measured: 0, 1 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Palacios
- Sponsor type
- University, hospital or other
- Collaborators
- Ferrer Internacional S.A.
- Responsible party
- Sponsor
- Investigators
- Santiago Palacios, MD, Study director, President of the European Foundation Woman and Health,Past President and Honorary Member of the Spanish Menopause Society, President of the Council of Affiliated Menopause Societies (CAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195609
- Sponsor's protocol ID
- IP-2013-01
- Acronym
- OMEGASI
- Status last verified
- Sep 2016
- First submitted
- 15 Jul 2014
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label Study to Evaluate the Effect of (Omega-3) EPA + Docosahexaenoic Acid (DHA) vs Soy Isoflavones in 100 Postmenopausal Women Between 45-65 Years With Moderate to Severe Vasomotor Symptoms.
- ClinicalTrials.gov ID
- NCT02195609
- Acronym / sponsor ID
- OMEGASI / IP-2013-01
- Conditions
- Menopause, Hot Flashes
- Keywords
- Vasomotor Symptoms Associated With Menopause, Menopause, Hot Flashes, Postmenopausal Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Instituto PalaciosUniversity, hospital or other
- Collaborators
- Ferrer Internacional S.A.
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Jul 2014 (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.
This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women treated for 4 months with Omega-3 vs Soy Isoflavones.
Detailed description
This is a non-inferiority study of Omega 3 versus Soy Isoflavones, being each patient its own control from the baseline.
In order to determine the difference observed in the evolution of intensity, frequency and the total number of hot flashes in 4 months in patients treated with Omega-3 vs Soy Isoflavones, is planned to include at least 100 patients, 50 per treatment arm.
It si estimated a standar deviation of 0.5%, and a 10% lost follow-up rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Other | Dietary Supplement: Omega-3600 mg (EPA, DHA and Omega-3) twice a day |
| Soy Isoflavones | Other | Dietary Supplement: Soy Isoflavones54.4mg oral twice a day |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ambulatory and can complete all study procedures, which are able to read, understand and sign an informed consent and willing to come to the center for study visits.
- Postmenopausal (≥ 1 year of amenorrhea) or 6 months or more of amenorrhea with follicle stimulating hormone (FSH) ≥ 40 IU / L.
- BMI ≥ 18 kg/m2 and ≤ 30 kg/m2
- Flushing of moderate to severe intensity.
Key exclusion criteria (17 listed)
- Women with surgical menopause.
- Treatment with hormone replacement therapy (HRT) in the 3 months prior to inclusion
- Uterine bleeding after menopause with undetermined cause in the 12 months prior to screening.
- Presence or history of malignancy in the past 5 years.
- Malabsorption syndrome.
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 |
|---|---|---|
| Omega-3Also: Om3gafort600 mg oral twice a day | Dietary supplement | Omega-3 |
| Soy IsoflavonesAlso: Flavia54.4 mg oral twice a day | Dietary supplement | Soy Isoflavones |
Primary outcome
Evaluate the changes in vasomotor symptoms.
Time frame: 0 to 4 months
To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .
9 secondary outcomes
Cardiovascular risk factors
Time frame: 0 and 4 months
Satisfaction with treatment
Time frame: at month 1 and 4
Mood status
Time frame: 0, 1 and 4 months
General health status
Time frame: months 0, 1 and 4
Rating memory status
Time frame: at 0, 1 and 4 months
Cardiovascular risk factors
Time frame: 0 amd 4 months
Cardiovascular risk factors
Time frame: 0, 1 and 4 months
Cardiovascular risk factors
Time frame: 0, 1 and 4 months
Cardiovascular risk factors
Time frame: 0, 1 and 4 months
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 16 Sep 2016.
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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.
Santiago Palacios, MD study director
President of the European Foundation Woman and Health,Past President and Honorary Member of the Spanish Menopause Society, President of the Council of Affiliated Menopause Societies (CAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 and Soy Isoflavones in people with Menopause and Hot Flashes, run by Instituto Palacios at 1 site in Spain.
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 4 inclusion and 17 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 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate the changes in vasomotor symptoms. (time frame: 0 to 4 months). 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 16 Sep 2016.