search
Back to results

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

Primary Purpose

Menopause, Hot Flashes

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Omega-3
Soy Isoflavones
Sponsored by
Instituto Palacios
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Menopause focused on measuring Vasomotor Symptoms Associated With Menopause, Menopause, Hot Flashes, Postmenopausal Women

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

  • 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.

Sites / Locations

  • Instituto Palacios

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Omega-3

Soy Isoflavones

Arm Description

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

54.4mg oral twice a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiovascular risk factors
serum cholesterol
Satisfaction with treatment
Treatment Satisfaction Questionnaire for Medication
Mood status
Hospital Anxiety and Depression Scale (HADS)
General health status
General health status by Short-Form 36 (SF-36) questionnaire
Rating memory status
Alteration of the memory test (T@M)
Cardiovascular risk factors
serum triglycerides
Cardiovascular risk factors
Blood pressure
Cardiovascular risk factors
Body mass index
Cardiovascular risk factors
abdominal circumference

Full Information

First Posted
July 15, 2014
Last Updated
September 15, 2016
Sponsor
Instituto Palacios
Collaborators
Ferrer Internacional S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT02195609
Brief Title
Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
Acronym
OMEGASI
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Palacios
Collaborators
Ferrer Internacional S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Hot Flashes
Keywords
Vasomotor Symptoms Associated With Menopause, Menopause, Hot Flashes, Postmenopausal Women

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Other
Arm Description
600 mg (EPA, DHA and Omega-3) twice a day
Arm Title
Soy Isoflavones
Arm Type
Other
Arm Description
54.4mg oral twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Other Intervention Name(s)
Om3gafort
Intervention Description
600 mg oral twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy Isoflavones
Other Intervention Name(s)
Flavia
Intervention Description
54.4 mg oral twice a day
Primary Outcome Measure Information:
Title
Evaluate the changes in vasomotor symptoms.
Description
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 Outcome Measure Information:
Title
Cardiovascular risk factors
Description
serum cholesterol
Time Frame
0 and 4 months
Title
Satisfaction with treatment
Description
Treatment Satisfaction Questionnaire for Medication
Time Frame
at month 1 and 4
Title
Mood status
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
0, 1 and 4 months
Title
General health status
Description
General health status by Short-Form 36 (SF-36) questionnaire
Time Frame
months 0, 1 and 4
Title
Rating memory status
Description
Alteration of the memory test (T@M)
Time Frame
at 0, 1 and 4 months
Title
Cardiovascular risk factors
Description
serum triglycerides
Time Frame
0 amd 4 months
Title
Cardiovascular risk factors
Description
Blood pressure
Time Frame
0, 1 and 4 months
Title
Cardiovascular risk factors
Description
Body mass index
Time Frame
0, 1 and 4 months
Title
Cardiovascular risk factors
Description
abdominal circumference
Time Frame
0, 1 and 4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Palacios, MD
Organizational Affiliation
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)
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Palacios
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs