Genistein and Endometrial Hyperplasia

Endometrial Hyperplasia Clinical Trial

Official title:

Effect of Genistein on Endometrial Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453960
• Other study ID #: Roberta Granese, MD, PhD
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2007
• Last updated: December 18, 2008
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 44 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Italy	Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery from endometrial hyperplasia		3-6 months	Yes
Secondary	Differential expression of ER-a and ER-b in endometrial specimens		6 months	Yes