Flaxseed Lignan (Brevail)
Completed · Early Phase 1
Conditions studied: Polycystic Ovarian Syndrome
In brief
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.
Key facts
- Study ID
- NCT01396369
- Run by
- University of Kansas Medical Center
- People needed
- 9
- Starts
- 2011-06-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2016-01-08
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The University of Kansas Medical Center — Kansas City, Kansas, United States
Full record on ClinicalTrials.gov
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