Genistein and Endometrial Hyperplasia - Full Text View

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

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	Phase
Endometrial Hyperplasia	Dietary Supplement: Genivis Drug: Norethisterone Acetate Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Effect of Genistein on Endometrial Hyperplasia

Resource links provided by NLM:

Drug Information available for: Norethindrone acetate Norethindrone Genistein

U.S. FDA Resources

Further study details as provided by University of Messina:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	59
Study Start Date:	January 2007
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Genistein Genistein 54 mg/day	Dietary Supplement: Genivis 54 mg/day daily for 6 months Other Name: Fosteum
Active Comparator: Norethisterone Acetate Norethisterone Acetate 10mg/day	Drug: Norethisterone Acetate tablets 10mg/day from day 16 to 25 of menstruation
Placebo Comparator: Placebo Placebo tablets, daily	Other: placebo tablets daily for 6 months

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 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

Contacts and Locations

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

Locations

Italy
Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"
Messina, Italy, 98100

Sponsors and Collaborators

University of Messina

Investigators

Study Director:

Rosario D'Anna, prof.

menopause centre

More Information

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.

Responsible Party:	University of Messina
ClinicalTrials.gov Identifier:	NCT00453960 History of Changes
Other Study ID Numbers:	Roberta Granese, MD, PhD
Study First Received:	March 28, 2007
Last Updated:	December 18, 2008
Health Authority:	Italy: National Institute of Health

Keywords provided by University of Messina:

Endometrial hyperplasia
Genistein
Isoflavones
dysfunctional uterine bleeding

Additional relevant MeSH terms:

Endometrial Hyperplasia
Hyperplasia
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Norethindrone
Norethindrone acetate
Genistein
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012