NCT00453960

Genistein and Endometrial Hyperplasia

Effect of Genistein on Endometrial Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Messina · Academic / Other
• Sex: Female
• Age: 44 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Hyperplasia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Genivis	54 mg/day daily for 6 months
DRUG	Norethisterone Acetate	tablets 10mg/day from day 16 to 25 of menstruation
OTHER	placebo	tablets daily for 6 months

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2007-03-29
• Last updated: 2008-12-19

Locations

1 site across 1 country: Italy