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

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.

Study Overview

• Status: Completed
• Conditions: Hot Flashes; Menopause
• Intervention / Treatment: Dietary supplement: Omega-3; Dietary supplement: 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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Instituto Palacios

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Omega-3; 600 mg (EPA, DHA and Omega-3) twice a day	Dietary supplement: Omega-3; 600 mg oral twice a day; Other Names: Om3gafort
Other: Soy Isoflavones; 54.4mg oral twice a day	Dietary supplement: Soy Isoflavones; 54.4 mg oral twice a day; Other Names: Flavia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the changes in vasomotor symptoms.	To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .	0 to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular risk factors	serum cholesterol	0 and 4 months
Satisfaction with treatment	Treatment Satisfaction Questionnaire for Medication	at month 1 and 4
Mood status	Hospital Anxiety and Depression Scale (HADS)	0, 1 and 4 months
General health status	General health status by Short-Form 36 (SF-36) questionnaire	months 0, 1 and 4
Rating memory status	Alteration of the memory test (T@M)	at 0, 1 and 4 months
Cardiovascular risk factors	serum triglycerides	0 amd 4 months
Cardiovascular risk factors	Blood pressure	0, 1 and 4 months
Cardiovascular risk factors	Body mass index	0, 1 and 4 months
Cardiovascular risk factors	abdominal circumference	0, 1 and 4 months

Collaborators and Investigators

• Sponsor: Instituto Palacios
• Collaborators: Ferrer Internacional S.A.
• Investigators: Study Director: Santiago Palacios, MD, 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)

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 18, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Menopause; Postmenopausal Women; Vasomotor Symptoms Associated With Menopause; Hot Flashes
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: IP-2013-01