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Genistein and Endometrial Hyperplasia

Primary Purpose

Endometrial Hyperplasia

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Genivis
Norethisterone Acetate
placebo
Sponsored by
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Hyperplasia focused on measuring Endometrial hyperplasia, Genistein, Isoflavones, dysfunctional uterine bleeding

Eligibility Criteria

44 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Genistein

Norethisterone Acetate

Placebo

Arm Description

Genistein 54 mg/day

Norethisterone Acetate 10mg/day

Placebo tablets, daily

Outcomes

Primary Outcome Measures

Recovery from endometrial hyperplasia

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2007
Last Updated
December 18, 2008
Sponsor
University of Messina
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1. Study Identification

Unique Protocol Identification Number
NCT00453960
Brief Title
Genistein and Endometrial Hyperplasia
Official Title
Effect of Genistein on Endometrial Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Messina

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia
Keywords
Endometrial hyperplasia, Genistein, Isoflavones, dysfunctional uterine bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genistein
Arm Type
Experimental
Arm Description
Genistein 54 mg/day
Arm Title
Norethisterone Acetate
Arm Type
Active Comparator
Arm Description
Norethisterone Acetate 10mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets, daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Genivis
Other Intervention Name(s)
Fosteum
Intervention Description
54 mg/day daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Norethisterone Acetate
Intervention Description
tablets 10mg/day from day 16 to 25 of menstruation
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
tablets daily for 6 months
Primary Outcome Measure Information:
Title
Recovery from endometrial hyperplasia
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Differential expression of ER-a and ER-b in endometrial specimens
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosario D'Anna, prof.
Organizational Affiliation
menopause centre
Official's Role
Study Director
Facility Information:
Facility Name
Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"
City
Messina
ZIP/Postal Code
98100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
12466350
Citation
Kayisli UA, Aksu CA, Berkkanoglu M, Arici A. Estrogenicity of isoflavones on human endometrial stromal and glandular cells. J Clin Endocrinol Metab. 2002 Dec;87(12):5539-44. doi: 10.1210/jc.2002-020716.
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Genistein and Endometrial Hyperplasia

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