Genistein and Endometrial Hyperplasia

University of Messina

Status and phase: Completed; Phase 2

Conditions: Endometrial Hyperplasia

Treatments: Drug: Norethisterone Acetate; Dietary Supplement: Genivis; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00453960

Roberta Granese, MD, PhD

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 patients

Sex: Female

Ages: 44 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 3 patient groups, including a placebo group

Genistein

Experimental group

Description:

Genistein 54 mg/day

Treatment:

Dietary Supplement: Genivis

Norethisterone Acetate

Active Comparator group

Description:

Norethisterone Acetate 10mg/day

Treatment:

Drug: Norethisterone Acetate

Placebo

Placebo Comparator group

Description:

Placebo tablets, daily

Treatment:

Other: placebo