A Phase 2 interventional study of Genivis and Norethisterone Acetate in Endometrial Hyperplasia, sponsored by University of Messina. Completed at 1 site in Italy. Open to female participants aged 44 Years to 55 Years. Per ClinicalTrials.gov, last updated 2008-12-19.
Sponsored by University of Messina · Phase 2, Interventional, and Treatment
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.
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.
103 studies on the registry are indexed under Endometrial Hyperplasia; 35 are open to participants now.
This study's enrollment of 59 is below the median of 76 across 66 interventional studies indexed under Endometrial Hyperplasia.
Browse Endometrial Hyperplasia studies →University of Messina is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Genistein 54 mg/day
Dietary Supplement: Genivis
Norethisterone Acetate 10mg/day
Drug: Norethisterone Acetate
Placebo tablets, daily
Other: placebo
54 mg/day daily for 6 months
Also known as: Fosteum
tablets 10mg/day from day 16 to 25 of menstruation
tablets daily for 6 months
Recovery from endometrial hyperplasia
Time frame: 3-6 months
Differential expression of ER-a and ER-b in endometrial specimens
Time frame: 6 months
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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University of Messina