Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe… (NCT02195609) | Clinical Trial Compass
CompletedPhase 4
Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
Spain75 participantsStarted 2014-03
Plain-language summary
This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women treated for 4 months with Omega-3 vs Soy Isoflavones.
Who can participate
Age range45 Years – 65 Years
SexFEMALE
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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 d…