CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 248 enrolled
Drug / intervention
Soy isoflavones +1 moredietary
Likely dose
Soy isoflavones 200 mg orally in tablet formAI-extracted
Key inclusion· 1
  • Postmenopausal: no menstrual period for 12 months or no period for 6-12 months with FSH >40 IU/L
Key exclusion· 11
  • Prior estrogen, progesterone, raloxifene, or tamoxifen therapy
  • Prior bisphosphonates, calcitonin, fluoride, or systemic corticosteroids
  • Soy or herbal supplements (including DHEA) within 3 months
  • Antibiotics in the month prior to study entry

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

Search/NCT00076050
NCT00076050Phase 3Completed

Bone Sparing Effects of Soy Phytoestrogens in Menopause

University of Miami·interventional·Posted Jan 14, 2004·Updated Dec 6, 2016

In Brief

A Phase 3 clinical trial evaluating Soy isoflavones and Placebo for Menopause and 2 related conditions. Completed, enrolled 248 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause. Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally occurring spinal bone loss and improve biological and other emotional changes of menopause.

Study Details

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

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 14, 2004
Enrollment StartSep 1, 2003
Primary CompletionMar 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 22.5 years ago

Interventions

Soy isoflavonesdietary

Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.

Placebodietary

Placebo soy isoflavones