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NCT00693082 · ClinicalTrials.gov registry record · Phase 2

Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

A Phase 2 study, sponsored by Duke University.

Terminated
Registry status
Phase 2
Development phase
4
Enrollment target

NCT00693082: Clinical Trial Phase 2 study, sponsored by Duke University.

NCT00693082 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00693082, a Phase 2 study, was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study Summary

The overall aim of this study is to explore the effects of flaxseed supplementation and determine whether it is a feasible and potentially effective dietary intervention among women with polycystic ovarian syndrome (PCOS). Women, ages 18-45, with clinically confirmed PCOS (N=20) will be scheduled for baseline measures and then instructed and given supplies necessary to follow a flaxseed supplemented (30 g/day) diet for a period of three months, whereupon follow-up measures will be taken. Subjects will be asked to resume their typical (unsupplemented) diet for another three months and a second set of follow-up measures will be taken. Baseline levels of bioavailable and total testosterone, fasting insulin, glucose, and triglycerides (TG), total/LDL/HDL cholesterol, body weight, degree of hirsutism and acne, and menstrual cyclicity will be compared to levels at 3 and 6 month follow-up. The overall hypothesis (based upon our work in men at risk for prostate cancer and data from one case-study conducted in a woman with confirmed PCOS) is that during the time women receive flaxseed supplementation they will experience reduced serum levels of testosterone, and total and LDL cholesterol, as well as clinical evidence of hirsutism. Given the pilot nature of this study, statistical analyses will be limited to simple descriptive statistics. We have observed no negative side effects, other than minor gastro-intestinal occurrences (i.e., temporary increased flatulence, borborygmi, increased number of stools, etc.) associated with flaxseed supplementation in our previous studies either with short or long-term use. Flaxseed supplementation will be discontinued if indicated and the events reported to the institutional review board.

Interventions

  • DIETARY_SUPPLEMENT flaxseed

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2007-08
Est. Completion 2009-06
Phase Phase 2
Duke University

1,725 total trials

Why NCT00693082 stopped before completion

NCT00693082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which flaxseed is the first listed.

NCT00693082 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00693082 about?

NCT00693082 is a clinical study titled "Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation". The overall aim of this study is to explore the effects of flaxseed supplementation and determine whether it is a feasible and potentially effective dietary intervention among women with polycystic ovarian syndrome (PCOS). Women, ages 18-45, with clinically confirmed PCOS (N=20) will be scheduled fo...

What is the current status of trial NCT00693082?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2007-08. Estimated completion is 2009-06.

What interventions are being tested in trial NCT00693082?

The interventions under investigation include: flaxseed (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00693082?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00693082's enrollment target sits among peer trials

4 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00693082, the US trial registry maintained by the National Library of Medicine. NCT00693082 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.