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Genistein and Endometrial Hyperplasia
This study has been completed.
Study NCT00453960   Information provided by University of Messina
First Received: March 28, 2007   Last Updated: December 18, 2008   History of Changes

March 28, 2007
December 18, 2008
January 2007
November 2008   (final data collection date for primary outcome measure)
Recovery from endometrial hyperplasia [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
recovery from endometrial hyperplasia
Complete list of historical versions of study NCT00453960 on ClinicalTrials.gov Archive Site
Differential expression of ER-a and ER-b in endometrial specimens [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
 
Genistein and Endometrial Hyperplasia
Effect of Genistein on Endometrial Hyperplasia

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

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.

Phase II
Interventional
Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Endometrial Hyperplasia
  • Dietary Supplement: Genivis
  • Drug: Norethisterone Acetate
  • Other: placebo
  • Experimental: Genistein 54 mg/day
  • Active Comparator: Norethisterone Acetate 10mg/day
  • Placebo Comparator: Placebo tablets, daily
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.
 
Completed
59
December 2008
November 2008   (final data collection date for primary outcome measure)

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
Female
44 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00453960
University of Messina, University of Messina
Roberta Granese, MD, PhD
University of Messina
 
Study Director: Rosario D'Anna, prof. menopause centre
University of Messina
December 2008

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