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Flaxseed Lignan (Brevail)

Primary Purpose

Polycystic Ovarian Syndrome

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Birth control
Birth control plus Brevail
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Birth control

Birth control plus Brevail

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary outcomes to assess are the lipid profile and estrogen levels.

Full Information

First Posted
July 14, 2011
Last Updated
January 6, 2016
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01396369
Brief Title
Flaxseed Lignan (Brevail)
Official Title
Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Birth control
Arm Type
Active Comparator
Arm Title
Birth control plus Brevail
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Birth control
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Birth control plus Brevail
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary outcomes to assess are the changes of testosterone levels and hirsutism.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Secondary outcomes to assess are the lipid profile and estrogen levels.
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Kim, MD
Organizational Affiliation
The University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Flaxseed Lignan (Brevail)

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