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Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms

NCT00076050 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2016-12-06

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Soy isoflavones

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

DIETARY_SUPPLEMENT

Placebo

Placebo soy isoflavones

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • University of Miami

    lead OTHER

Principal Investigators

  • Silvina Levis, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2009-03-31
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00076050 on ClinicalTrials.gov