Status:
COMPLETED
Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
Lead Sponsor:
Instituto Palacios
Collaborating Sponsors:
Ferrer Internacional S.A.
Conditions:
Menopause
Hot Flashes
Eligibility:
FEMALE
45-65 years
Phase:
PHASE4
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, f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02195609
Start Date
March 1 2014
End Date
November 1 2015
Last Update
September 16 2016
Active Locations (1)
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1
Instituto Palacios
Madrid, Madrid, Spain, 28009