Genistein and Endometrial Hyperplasia

Phase 2

Completed

• Conditions: Endometrial Hyperplasia
• Interventions: Dietary Supplement: Genivis; Drug: Norethisterone Acetate; Other: placebo

• Registration Number: NCT00453960
• Lead Sponsor: University of Messina

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-03-28
• Study First Submitted QC: 2007-03-28
• Study First Posted: 2007-03-29
• Primary Completion: 2008-11
• Status Verified: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2008-12-18
• Last Update Posted: 2008-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genistein	Genivis	Genistein 54 mg/day
Norethisterone Acetate	Norethisterone Acetate	Norethisterone Acetate 10mg/day
Placebo	placebo	Placebo tablets, daily

Primary Outcome Measures

Name	Time	Method
Recovery from endometrial hyperplasia	3-6 months

Secondary Outcome Measures

Name	Time	Method
Differential expression of ER-a and ER-b in endometrial specimens	6 months

Trial Locations

Locations (1)

Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"; 🇮🇹 Messina, Italy