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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-11-30

Brief Summary

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This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women treated for 4 months with Omega-3 vs Soy Isoflavones.

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Detailed Description

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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

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Menopause Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Omega-3

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

Group Type OTHER

Omega-3

Intervention Type DIETARY_SUPPLEMENT

600 mg oral twice a day

Soy Isoflavones

54.4mg oral twice a day

Group Type OTHER

Soy Isoflavones

Intervention Type DIETARY_SUPPLEMENT

54.4 mg oral twice a day

Interventions

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Omega-3

600 mg oral twice a day

Intervention Type DIETARY_SUPPLEMENT

Soy Isoflavones

54.4 mg oral twice a day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Om3gafort Flavia

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Santiago Palacios, MD

Role: 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)