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

Menopause Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195609
• Other study ID #: IP-2013-01
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2014
• Last updated: September 15, 2016
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Dietary Supplement:
• Omega-3
600 mg oral twice a day
• Soy Isoflavones
54.4 mg oral twice a day

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Palacios	Ferrer Internacional S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cardiovascular risk factors	serum cholesterol	0 and 4 months	No
Secondary	Satisfaction with treatment	Treatment Satisfaction Questionnaire for Medication	at month 1 and 4	No
Secondary	Mood status	Hospital Anxiety and Depression Scale (HADS)	0, 1 and 4 months	No
Secondary	General health status	General health status by Short-Form 36 (SF-36) questionnaire	months 0, 1 and 4	No
Secondary	Rating memory status	Alteration of the memory test (T@M)	at 0, 1 and 4 months	No
Secondary	Cardiovascular risk factors	serum triglycerides	0 amd 4 months	No
Secondary	Cardiovascular risk factors	Blood pressure	0, 1 and 4 months	No
Secondary	Cardiovascular risk factors	Body mass index	0, 1 and 4 months	No
Secondary	Cardiovascular risk factors	abdominal circumference	0, 1 and 4 months	No