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Flaxseed Lignan (Brevail)

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University of Kansas

Status and phase

Completed
Early Phase 1

Conditions

Polycystic Ovarian Syndrome

Treatments

Drug: Birth control
Drug: Birth control plus Brevail

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

9 participants in 2 patient groups

Birth control
Active Comparator group
Treatment:
Drug: Birth control
Birth control plus Brevail
Experimental group
Treatment:
Drug: Birth control plus Brevail

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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