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NCT01396369 · ClinicalTrials.gov registry record · Early Phase 1

Flaxseed Lignan (Brevail)

A Early Phase 1 study of Polycystic Ovarian Syndrome, sponsored by University of Kansas Medical Center.

Completed
Registry status
Early Phase 1
Development phase
9
Enrollment target
1
Study location

NCT01396369: Completed Early Phase 1 study of Polycystic Ovarian Syndrome, sponsored by University of Kansas Medical Center.

NCT01396369 is a Early Phase 1 study of Polycystic Ovarian Syndrome that has completed, run by University of Kansas Medical Center. The registered enrollment target is 9 participants, below the 42-participant average among 4 other Polycystic Ovarian Syndrome trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01396369, a Early Phase 1 study of Polycystic Ovarian Syndrome, has completed, sponsored by University of Kansas Medical Center.

COMPLETED
Registry status
Early Phase 1
Development phase
9 participants
Enrollment target
1
Study location

Study 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 Studied

Polycystic Ovarian Syndrome

Interventions

  • DRUG Birth control
  • DRUG Birth control plus Brevail

Study Locations (1)

Kansas

  • The University of Kansas Medical Center - Kansas City

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2011-06
Est. Completion 2013-12
Phase Early Phase 1
University of Kansas Medical Center

408 total trials

What the finished NCT01396369 record still lists

NCT01396369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 42-participant average among 4 other Polycystic Ovarian Syndrome trials with a reported enrollment target (79% lower).

The record links to 1 condition, with Polycystic Ovarian Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Birth control is the first listed.

NCT01396369 reports a single indexed study location in Kansas.

Frequently Asked Questions

What is clinical trial NCT01396369 about?

NCT01396369 is a clinical study titled "Flaxseed Lignan (Brevail)". 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...

What is the current status of trial NCT01396369?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2011-06. Estimated completion is 2013-12.

What conditions does trial NCT01396369 study?

This clinical trial studies the following conditions: Polycystic Ovarian Syndrome.

What interventions are being tested in trial NCT01396369?

The interventions under investigation include: Birth control (DRUG), Birth control plus Brevail (DRUG).

Who is sponsoring clinical trial NCT01396369?

This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01396369 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01396369, the US trial registry maintained by the National Library of Medicine. NCT01396369 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.