Clinical trial NCT02195609: Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Hot Flashes
Keywords: Vasomotor Symptoms Associated With Menopause
Menopause
Hot Flashes
Postmenopausal Women
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
Collaborators: name: Ferrer Internacional S.A.
First posted: 2014-07-21
Enrollment: 75
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Evaluate the changes in vasomotor symptoms.
timeFrame: 0 to 4 months
Secondary outcomes:
measure: Cardiovascular risk factors
timeFrame: 0 and 4 months
measure: Satisfaction with treatment
timeFrame: at month 1 and 4
measure: Mood status
timeFrame: 0, 1 and 4 months
measure: General health status
timeFrame: months 0, 1 and 4
measure: Rating memory status
timeFrame: at 0, 1 and 4 months
measure: Cardiovascular risk factors
timeFrame: 0 amd 4 months
measure: Cardiovascular risk factors
timeFrame: 0, 1 and 4 months
measure: Cardiovascular risk factors
timeFrame: 0, 1 and 4 months
measure: Cardiovascular risk factors
timeFrame: 0, 1 and 4 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
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)
name: Santiago Palacios, MD
role: STUDY_DIRECTOR
References: