Effect of Genistein on Endometrial Hyperplasia
44 Years
55 Years
Female
Endometrial Hyperplasia
Trial Information
Effect of Genistein on Endometrial Hyperplasia
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 they act as antiestrogens.
Considered that endometrial hyperplasia is due to strong and extended estrogenic
stimulation, not offset by a proportionate amount of progesterone, we suppose that genistein
could be therapeutic in these cases inducing a decrease of the hyperplasia and a change from
the proliferative to a secretory phase of the endometrium.
Inclusion Criteria:
- 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 Criteria:
- All the other conditions
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Recovery from endometrial hyperplasia
Outcome Time Frame:
3-6 months
Safety Issue:
Yes
Principal Investigator
Rosario D'Anna, prof.
Investigator Role:
Study Director
Investigator Affiliation:
menopause centre
Authority:
Italy: National Institute of Health
Study ID:
Roberta Granese, MD, PhD
NCT ID:
NCT00453960
Start Date:
January 2007
Completion Date:
December 2008
Related Keywords:
- Endometrial Hyperplasia
- Endometrial hyperplasia
- Genistein
- Isoflavones
- dysfunctional uterine bleeding
- Endometrial Hyperplasia
- Hyperplasia
- Adenoma
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