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Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome


N/A
18 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovarian Syndrome

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Trial Information

Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary outcomes to assess are the changes of testosterone levels and hirsutism.

Outcome Time Frame:

up to 6 months

Safety Issue:

No

Principal Investigator

Sam Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Kansas Medical Center

Authority:

United States: Institutional Review Board

Study ID:

12459

NCT ID:

NCT01396369

Start Date:

June 2011

Completion Date:

June 2013

Related Keywords:

  • Polycystic Ovarian Syndrome
  • Polycystic Ovary Syndrome

Name

Location

The University of Kansas Medical CenterKansas City, Kansas  66160