NCT02195609

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Instituto Palacios · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menopause
• Hot Flashes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3	600 mg oral twice a day
DIETARY_SUPPLEMENT	Soy Isoflavones	54.4 mg oral twice a day

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2014-07-21
• Last updated: 2016-09-16

Locations

1 site across 1 country: Spain