Genistein and Endometrial Hyperplasia - Full Text View

Purpose

The aim of this study is to verify the anti-estrogenic activity of Genistein, on the “non atypical endometrial hyperplasia”, in premenopausal women.

Condition	Intervention
Endometrial Hyperplasia	Drug: Genistein

ChemIDplus related topics:

Genistein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Effect of Genistein on Endometrial Hyperplasia

Further study details as provided by University of Messina:

Primary Outcome Measures:

recovery from endometrial hyperplasia

Estimated Enrollment:	50
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008

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.

Eligibility

Ages Eligible for Study:	44 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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
No intrauterine pathologies (polyps, myomas)
A “non atypical endometrial hyperplasia”, confirmed by hysteroscopy with biopsy and histological examination

Exclusion Criteria:

All the other conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453960

Contacts


Contact: Roberta Granese, MD	0039 3470036861	robertagr74@gmail.com

Locations


Italy
	Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"	Recruiting
	Messina, Italy, 98100
	Contact: Roberta Granese, MD 0039 347 0036861 robertagr74@gmail.com
	Contact: Rosario D'Anna, Prof. 0039 330 831044 rosariodanna@tin.it

Sponsors and Collaborators

University of Messina

Investigators


Study Director:	Rosario D'Anna, prof.	menopause centre

More Information

Publications of Results:

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.

Study ID Numbers:	Roberta Granese, MD
First Received:	March 28, 2007
Last Updated:	March 28, 2007
ClinicalTrials.gov Identifier:	NCT00453960
Health Authority:	Italy: National Institute of Health

Keywords provided by University of Messina:

Endometrial hyperplasia

Genistein

Isoflavones

dysfunctional uterine bleeding

Study placed in the following topic categories:

Genital Diseases, Female

Hyperplasia

Metrorrhagia

Uterine Hemorrhage

Uterine Diseases

Hemorrhage

Genistein

Endometrial Hyperplasia

Additional relevant MeSH terms:

Anticarcinogenic Agents

Estrogens

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors

Hormones

Protective Agents

Protein Kinase Inhibitors

Pharmacologic Actions

Pathologic Processes

Estrogens, Non-Steroidal

Therapeutic Uses

Phytoestrogens

ClinicalTrials.gov processed this record on October 20, 2008

Sponsored by:	University of Messina
Information provided by:	University of Messina
ClinicalTrials.gov Identifier:	NCT00453960