Status:

COMPLETED

Genistein and Endometrial Hyperplasia

Lead Sponsor:

University of Messina

Conditions:

Endometrial Hyperplasia

Eligibility:

FEMALE

44-55 years

Phase:

PHASE2

Brief Summary

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

Detailed Description

Although isoflavones alone (example: Genistein) have weak estrogenic effects on endometrial stromal and glandular cells, it was demonstrated, in several research efforts, that in the presence of E2 th...

Eligibility Criteria

Inclusion

  • Premenopausal women
  • Age \> = 44 years
  • Dysfunctional uterine bleeding
  • No treatment with other hormonal drugs (estrogen, progesterone)
  • No local or general pathology negatively influenced by administration of genistein or progesterone
  • No intrauterine pathologies (polyps, myomas)
  • A "non atypical endometrial hyperplasia", confirmed by hysteroscopy with biopsy and histological examination

Exclusion

  • All the other conditions

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

59 Patients enrolled

Trial Details

Trial ID

NCT00453960

Start Date

January 1 2007

End Date

December 1 2008

Last Update

December 19 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"

Messina, Italy, 98100