Flaxseed Lignan (Brevail)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Samuel Kim, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01396369
First received: July 14, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Polycystic Ovarian Syndrome
Drug: Birth control
Drug: Birth control plus Brevail

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Primary outcomes to assess are the changes of testosterone levels and hirsutism. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes to assess are the lipid profile and estrogen levels. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Birth control 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.
Experimental: Birth control plus Brevail 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396369

Contacts
Contact: Sam Kim, MD 913-588-2229 skim2@kumc.edu

Locations
United States, Kansas
The University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Sam Kim, MD    913-588-2229    skim2@kumc.edu   
Principal Investigator: Sam Kim, MD         
Sponsors and Collaborators
Samuel Kim, MD
Investigators
Principal Investigator: Sam Kim, MD The University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: Samuel Kim, MD, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01396369     History of Changes
Other Study ID Numbers: 12459
Study First Received: July 14, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014