Effect of Genistein on Endometrial Hyperplasia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Messina
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Recovery from endometrial hyperplasia
Study Overview
Brief Summary
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 44 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Genistein
Genistein 54 mg/day
Intervention: Genivis (Dietary Supplement)
Norethisterone Acetate
Norethisterone Acetate 10mg/day
Intervention: Norethisterone Acetate (Drug)
Placebo
Placebo tablets, daily
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Recovery from endometrial hyperplasia
Time Frame: 3-6 months
Secondary Outcomes
- Differential expression of ER-a and ER-b in endometrial specimens(6 months)