Endometrial Hyperplasia
Conditions
Keywords
Endometrial hyperplasia, Genistein, Isoflavones, dysfunctional uterine bleeding
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 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.
Interventions
DIETARY_SUPPLEMENTGenivis
54 mg/day daily for 6 months
tablets 10mg/day from day 16 to 25 of menstruation
OTHERplacebo
tablets daily for 6 months
Sponsors
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
44 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery from endometrial hyperplasia | 3-6 months |
Secondary
| Measure | Time frame |
|---|---|
| Differential expression of ER-a and ER-b in endometrial specimens | 6 months |
Countries
Italy
Outcome results
None listed