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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 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.
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
Interventions
- DRUG Birth control
- DRUG Birth control plus Brevail
Study Locations (1)
Kansas
- The University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01396369
The ClinicalTrials.gov registry entry for NCT01396369 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 42-participant average among 4 other Polycystic Ovarian Syndrome trials with a reported enrollment target (79% lower). The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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