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Third Year Evaluation on Genistein Efficacy and Safety

NCT00626769 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2009-05-19

No results posted yet for this study

Summary

BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone metabolism with no clinically significant adverse effects in a cohort of osteopenic, postmenopausal women. However, there is still a knowledge gap regarding the long-term safety of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal women.

OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year therapy with pure, standardized genistein (54 mg/day).

Conditions

Interventions

DIETARY_SUPPLEMENT

aglycone genistein

2 capsules per day containing 27 mg of aglycone genistein, calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.

DIETARY_SUPPLEMENT

placebo

2 capsules per day containing calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.

Sponsors & Collaborators

  • Primus Pharmaceuticals

    collaborator INDUSTRY

  • University of Messina

    lead OTHER

Principal Investigators

  • Francesco Squadrito, MD · University of Messina

  • Rosario D'Anna, MD · University of Messina

Eligibility

Min Age
49 Years
Max Age
67 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-07-31
Completion
2006-09-30

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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 NCT00626769 on ClinicalTrials.gov