Clinical trial · Interventional
Flaxseed Lignan (Brevail)
Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Birth control | Drug | — | UNRESOLVED |
| Birth control plus Brevail | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Birth control
- interventionNames
- Drug: Birth control
- type
- EXPERIMENTAL
- label
- Birth control plus Brevail
- interventionNames
- Drug: Birth control plus Brevail
Primary outcomes (1)
- measure
- Primary outcomes to assess are the changes of testosterone levels and hirsutism.
- timeFrame
- up to 6 months
Secondary outcomes (1)
- measure
- Secondary outcomes to assess are the lipid profile and estrogen levels.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available