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

NCT02195609 | Completed Phase 4 DMC

• 1 other identifier: IP-2013-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Hot Flashes

Keywords

Vasomotor Symptoms Associated With Menopause; Menopause; Hot Flashes; Postmenopausal Women

Outcome Measures

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 .

  0 to 4 months

Secondary Outcomes (9)

• Cardiovascular risk factors

  0 and 4 months

• Satisfaction with treatment

  at month 1 and 4

• Mood status

  0, 1 and 4 months

• General health status

  months 0, 1 and 4

• Rating memory status

  at 0, 1 and 4 months

Study Arms (2)

Omega-3

OTHER

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

Dietary Supplement: Omega-3

Soy Isoflavones

OTHER

54.4mg oral twice a day

Dietary Supplement: Soy Isoflavones

Interventions

Omega-3 DIETARY_SUPPLEMENT

600 mg oral twice a day

Also known as: Om3gafort

Omega-3

Soy Isoflavones DIETARY_SUPPLEMENT

54.4 mg oral twice a day

Also known as: Flavia

Soy Isoflavones

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women with surgical menopause.
• 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.

Sponsors & Collaborators

• Instituto Palacios: lead
• Ferrer Internacional S.A.: collaborator

Study Sites (1)

Instituto Palacios

Madrid, Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Docosahexaenoic Acids; Soybean Proteins

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 21, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 16, 2016

Record last verified: 2016-09

Locations

ES (1)