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Flaxseed Lignan (Brevail)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01396369
First received: July 14, 2011
Last updated: September 16, 2014
Last verified: September 2014

July 14, 2011
September 16, 2014
June 2011
December 2013   (final data collection date for primary outcome measure)
Primary outcomes to assess are the changes of testosterone levels and hirsutism. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01396369 on ClinicalTrials.gov Archive Site
Secondary outcomes to assess are the lipid profile and estrogen levels. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Flaxseed Lignan (Brevail)
Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovarian Syndrome
  • 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.
  • Active Comparator: Birth control
    Intervention: Drug: Birth control
  • Experimental: Birth control plus Brevail
    Intervention: Drug: Birth control plus Brevail
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01396369
12459
No
University of Kansas
University of Kansas
Not Provided
Principal Investigator: Sam Kim, MD The University of Kansas Medical Center
University of Kansas
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP