NCT01396369

Flaxseed Lignan (Brevail)

Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries. This study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (PCOS) patients.

Conditions

• Polycystic Ovarian Syndrome

Interventions

Type	Name	Description
DRUG	Birth control	In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H\&P as well as repeat ultrasound and blood tests.
DRUG	Birth control plus Brevail	In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H\&P as well as repeat ultrasound and blood tests.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-07-18
• Last updated: 2016-01-08

Locations

1 site across 1 country: United States