Flaxseed Lignan (Brevail)

NCT ID: NCT01396369

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Polycystic Ovarian Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Birth control

Group Type: ACTIVE_COMPARATOR

Birth control

Intervention Type: DRUG

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.

Birth control plus Brevail

Group Type: EXPERIMENTAL

Birth control plus Brevail

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

The University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

12459

Identifier Type: -

Identifier Source: org_study_id