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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1
Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"
Messina, Italy, 98100