CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
genistein +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00541710
NCT00541710Phase 3Completed
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Genistein Use in Postmenopausal Women With Metabolic Syndrome

University of Messina·interventional·Posted Oct 10, 2007·Updated Sep 14, 2012

In Brief

A Phase 3 clinical trial evaluating genistein and placebo for Metabolic Syndrome. Completed, enrolled 120 participants across 3 sites.

Detailed Summary

The purpose of this study is to determine whether the phytoestrogen genistein is effective in improving bone condition in pre-menopausal and post-menopausal women suffering for osteopenia. Since, during the study the investigators realized that at least 70% of post-menopausal recruited women suffered for metabolic syndrome (MS), we have added only in these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome
CountriesItaly
CollaboratorsMinistry of Education, Universities and Research, Italy

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2007
Enrollment StartOct 1, 2007
Primary CompletionJan 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.7 years ago

Interventions

genisteindietary

pills of 27 mg, twice per day for 12 months

placebodietary

sugar pills twice per day for 12 months