Genistein and Endometrial Hyperplasia - Tabular View

Tracking Information

First Received Date ^ICMJE

March 28, 2007

Last Updated Date

December 18, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Recovery from endometrial hyperplasia [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

recovery from endometrial hyperplasia

Change History

Complete list of historical versions of study NCT00453960 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Differential expression of ER-a and ER-b in endometrial specimens [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Genistein and Endometrial Hyperplasia

Official Title ^ICMJE

Effect of Genistein on Endometrial Hyperplasia

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Endometrial Hyperplasia

Intervention ^ICMJE

Dietary Supplement: Genivis
Drug: Norethisterone Acetate
Other: placebo

Study Arms / Comparison Groups

Experimental: Genistein 54 mg/day
Active Comparator: Norethisterone Acetate 10mg/day
Placebo Comparator: Placebo tablets, daily

Publications *

Kayisli UA, Aksu CA, Berkkanoglu M, Arici A. Estrogenicity of isoflavones on human endometrial stromal and glandular cells. J Clin Endocrinol Metab. 2002 Dec;87(12):5539-44.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

44 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00453960

Responsible Party

University of Messina, University of Messina

Study ID Numbers ^ICMJE

Roberta Granese, MD, PhD

Study Sponsor ^ICMJE

University of Messina

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Rosario D'Anna, prof.

menopause centre

Information Provided By

University of Messina

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP