Flaxseed Lignan (Brevail)

NCT01396369 | Completed Early Phase 1

• 1 other identifier: 12459
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  up to 6 months

Secondary Outcomes (1)

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

  Up to 6 months

Study Arms (2)

Birth control

ACTIVE COMPARATOR

Drug: Birth control

Birth control plus Brevail

EXPERIMENTAL

Drug: Birth control plus Brevail

Interventions

Birth control 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

Birth control plus Brevail 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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Contraception

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics

Study Officials

• Sam Kim, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

US (1)