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NCT00204490 · ClinicalTrials.gov registry record · Phase 2

Soy Isoflavones and Breast Cancer Risk Reduction

A Phase 2 study, sponsored by The University of Texas Medical Branch, Galveston.

Completed
Registry status
Phase 2
Development phase
197
Enrollment target

NCT00204490: Completed Phase 2 study, sponsored by The University of Texas Medical Branch, Galveston.

NCT00204490 is a Phase 2 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 197 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00204490, a Phase 2 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.

COMPLETED
Registry status
Phase 2
Development phase
197 participants
Enrollment target

Study Summary

Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.

Primary Outcome

Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.

Interventions

  • DIETARY_SUPPLEMENT isoflavones
  • DIETARY_SUPPLEMENT carbohydrate

Trial Details

FieldValue
Enrollment Target 197 participants
Start Date 2004-04
Est. Completion 2023-05-31
Phase Phase 2

What the finished NCT00204490 record still lists

NCT00204490 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher).

The record links to 0 conditions, and to 2 interventions - of which isoflavones is the first listed.

NCT00204490 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00204490 about?

NCT00204490 is a clinical study titled "Soy Isoflavones and Breast Cancer Risk Reduction". Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize ...

What is the current status of trial NCT00204490?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2004-04. Estimated completion is 2023-05-31.

What interventions are being tested in trial NCT00204490?

The interventions under investigation include: isoflavones (DIETARY_SUPPLEMENT), carbohydrate (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00204490?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00204490's enrollment target sits among peer trials

197 349th of 2000 higher than 1,652 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 NCT00204490, the US trial registry maintained by the National Library of Medicine. NCT00204490 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.