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Completed

NCT Number: NCT00453960

Genistein and 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.

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Key information

Conditions

Endometrial Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

44 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"

Messina, 98100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genivis

Dietary Supplement

54 mg/day daily for 6 months

Other names: Fosteum

Norethisterone acetate

Drug

tablets 10mg/day from day 16 to 25 of menstruation

Placebo

Other

tablets daily for 6 months

Primary outcomes

  1. Recovery from endometrial hyperplasia

    Time frame: 3-6 months

Secondary outcomes

  1. Differential expression of ER-a and ER-b in endometrial specimens

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Effect of Genistein on Endometrial Hyperplasia

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 29, 2007
Registry last updated
Dec 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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