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Genistein and Endometrial Hyperplasia

NCT00453960 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2008-12-19

No results posted yet for this study

Summary

The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.

Conditions

  • Endometrial Hyperplasia

Interventions

DIETARY_SUPPLEMENT

Genivis

54 mg/day daily for 6 months

DRUG

Norethisterone Acetate

tablets 10mg/day from day 16 to 25 of menstruation

OTHER

placebo

tablets daily for 6 months

Sponsors & Collaborators

  • University of Messina

    lead OTHER

Principal Investigators

  • Rosario D'Anna, prof. · menopause centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
44 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-11-30
Completion
2008-12-31

Countries

  • Italy

Study Locations

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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 NCT00453960 on ClinicalTrials.gov