Flaxseed Lignan (Brevail)

Early Phase 1

Completed

• Conditions: Polycystic Ovarian Syndrome
• Interventions: Drug: Birth control; Drug: Birth control plus Brevail

• Registration Number: NCT01396369
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

• Must be 18 to 40 year old female with:
• Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score >8, and/or hyperandrogenemia defined as total testosterone >80ng/dl or bioavailable testosterone >8.4 ng/dl.
• Mentally competent.

Exclusion Criteria

• Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
• Long-term or chronic use of oral antibiotics.
• Hysterectomy.
• FSH >15.
• Pregnancy/lactation.
• Consumption of flaxseed within the last month.
• Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
• Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Birth control	Birth control	-
Birth control plus Brevail	Birth control plus Brevail	-

Primary Outcome Measures

Name	Time	Method
Primary outcomes to assess are the changes of testosterone levels and hirsutism.	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes to assess are the lipid profile and estrogen levels.	Up to 6 months

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States