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Genistein and Endometrial Hyperplasia

Sponsor
University of Messina (Other)
Overall Status
Completed
CT.gov ID
NCT00453960
Collaborator
(none)
59
Enrollment
1
Location
3
Arms
23
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Genivis
  • Drug: Norethisterone Acetate
  • Other: placebo
 Phase 2

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
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Genistein on Endometrial Hyperplasia
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Genistein

Genistein 54 mg/day

Dietary Supplement: Genivis
54 mg/day daily for 6 months
Other Names:
  • Fosteum

    		•
    Active Comparator: Norethisterone Acetate

    Norethisterone Acetate 10mg/day

    Drug: Norethisterone Acetate
    tablets 10mg/day from day 16 to 25 of menstruation
    Placebo Comparator: Placebo

    Placebo tablets, daily

    Other: placebo
    tablets daily for 6 months

    Outcome Measures

    Primary Outcome Measures

    1. Recovery from endometrial hyperplasia [3-6 months]

    Secondary Outcome Measures

    1. Differential expression of ER-a and ER-b in endometrial specimens [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    44 Years to 55 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino" Messina Italy 98100

    Sponsors and Collaborators

    • University of Messina

    Investigators

    • Study Director: Rosario D'Anna, prof., menopause centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00453960
    Other Study ID Numbers:
    • Roberta Granese, MD, PhD
    First Posted:
    Mar 29, 2007
    Last Update Posted:
    Dec 19, 2008
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    Endometrial hyperplasia
    Genistein
    Isoflavones
    dysfunctional uterine bleeding
    Additional relevant MeSH terms:
    Endometrial Hyperplasia
    Hyperplasia
    Norethindrone
    Norethindrone Acetate

    Study Results

    No Results Posted as of Dec 19, 2008