CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 197 enrolled
Drug / intervention
isoflavones +1 moredietary
Likely dose
Soy isoflavones (Novasoy) 246 mg per tablet, two tablets daily for five days per week for up to 2 years; or carbohydrate placebo equivalentAI-extracted
Key inclusion· 4
  • Healthy premenopausal women
  • Age 30-42 years
  • Normal mammograms
  • Regular menstrual cycles
Key exclusion· 8
  • Abnormal mammograms
  • First-degree relatives with breast cancer
  • Pregnant or lactating
  • Peri- or post-menopausal status

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00204490
NCT00204490Phase 2Completed

Mammographic Density and Soy Isoflavones

The University of Texas Medical Branch, Galveston·interventional·Posted Sep 20, 2005·Updated May 16, 2024

In Brief

A Phase 2 clinical trial evaluating isoflavones and carbohydrate for Breast Cancer. Completed, enrolled 197 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartApr 1, 2004
Primary CompletionDec 10, 2012
Study CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 20.8 years ago

Interventions

isoflavonesdietary

soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.

carbohydratedietary

carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.