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Effect of Genistein on Endometrial Hyperplasia

Phase 2
44 Years
55 Years
Not Enrolling
Endometrial Hyperplasia

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Trial Information

Effect of Genistein on Endometrial Hyperplasia

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.

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

- No intrauterine pathologies (polyps, myomas)

- A "non atypical endometrial hyperplasia", confirmed by hysteroscopy with biopsy and
histological examination

Exclusion Criteria:

- All the other conditions

Type of Study:


Study Design:

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

Outcome Measure:

Recovery from endometrial hyperplasia

Outcome Time Frame:

3-6 months

Safety Issue:


Principal Investigator

Rosario D'Anna, prof.

Investigator Role:

Study Director

Investigator Affiliation:

menopause centre


Italy: National Institute of Health

Study ID:

Roberta Granese, MD, PhD



Start Date:

January 2007

Completion Date:

December 2008

Related Keywords:

  • Endometrial Hyperplasia
  • Endometrial hyperplasia
  • Genistein
  • Isoflavones
  • dysfunctional uterine bleeding
  • Endometrial Hyperplasia
  • Hyperplasia
  • Adenoma