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Genistein and Endometrial Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
University of Messina
ClinicalTrials.gov Identifier:
NCT00453960
First received: March 28, 2007
Last updated: December 18, 2008
Last verified: December 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 ]
Not Provided
Not Provided
Not Provided
 
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Endometrial Hyperplasia
  • Dietary Supplement: Genivis
    54 mg/day daily for 6 months
    Other Name: Fosteum
  • Drug: Norethisterone Acetate
    tablets 10mg/day from day 16 to 25 of menstruation
  • Other: placebo
    tablets daily for 6 months
  • Experimental: Genistein
    Genistein 54 mg/day
    Intervention: Dietary Supplement: Genivis
  • Active Comparator: Norethisterone Acetate
    Norethisterone Acetate 10mg/day
    Intervention: Drug: Norethisterone Acetate
  • Placebo Comparator: Placebo
    Placebo tablets, daily
    Intervention: Other: placebo
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 ClinicalTrials.gov Identifier (NCT Number) 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
Roberta Granese, MD, PhD
Yes
University of Messina
University of Messina
Not Provided
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