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CompletedNCT02195609OMEGASIUpdated Sep 16, 2016

Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

A Phase 4 interventional study of Omega-3 and Soy Isoflavones in Menopause and Hot Flashes, sponsored by Instituto Palacios. Completed at 1 site in Spain. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-16.

Sponsored by Instituto Palacios · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Menopause
  • Hot Flashes

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Keywords

  • Vasomotor Symptoms Associated With Menopause
  • Menopause
  • Hot Flashes
  • Postmenopausal Women
03

In context

Hot Flashes

293 studies on the registry are indexed under Hot Flashes; 52 are open to participants now.

This study's enrollment of 75 is below the median of 90 across 262 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Instituto Palacios is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Other
    Omega-3

    600 mg (EPA, DHA and Omega-3) twice a day

    Dietary Supplement: Omega-3

  • Other
    Soy Isoflavones

    54.4mg oral twice a day

    Dietary Supplement: Soy Isoflavones

Interventions

  • Dietary supplementOmega-3

    600 mg oral twice a day

    Also known as: Om3gafort

  • Dietary supplementSoy Isoflavones

    54.4 mg oral twice a day

    Also known as: Flavia

06

What researchers measure

Primary outcomes

  1. Evaluate the changes in vasomotor symptoms.

    To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .

    Time frame: 0 to 4 months

Secondary outcomes

  1. Cardiovascular risk factors

    serum cholesterol

    Time frame: 0 and 4 months

  2. Satisfaction with treatment

    Treatment Satisfaction Questionnaire for Medication

    Time frame: at month 1 and 4

  3. Mood status

    Hospital Anxiety and Depression Scale (HADS)

    Time frame: 0, 1 and 4 months

  4. General health status

    General health status by Short-Form 36 (SF-36) questionnaire

    Time frame: months 0, 1 and 4

  5. Rating memory status

    Alteration of the memory test (T@M)

    Time frame: at 0, 1 and 4 months

  6. Cardiovascular risk factors

    serum triglycerides

    Time frame: 0 amd 4 months

  7. Cardiovascular risk factors

    Blood pressure

    Time frame: 0, 1 and 4 months

  8. Cardiovascular risk factors

    Body mass index

    Time frame: 0, 1 and 4 months

  9. Cardiovascular risk factors

    abdominal circumference

    Time frame: 0, 1 and 4 months

07

Study locations

1 site
  • Instituto Palacios
    Madrid, Madrid 28009, Spain
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Sep 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2014
First posted
Jul 21, 2014
Start
Mar 2014
Primary completionActual
Sep 2015
CompletionActual
Nov 2015
Last update
Sep 16, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02195609
Lead sponsor
Instituto Palacios
Collaborators
Ferrer Internacional S.A.
Responsible party
Sponsor
First posted
Jul 21, 2014
Start date
Mar 2014
Primary completion
Sep 2015
Completion
Nov 2015
Last update
Sep 16, 2016

Study contacts

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)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Omega-3 fatty acid · Soy isoflavones

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