Genistein and Endometrial Hyperplasia | NCT00453960

Studies
Genistein and Endometrial Hyperplasia

NCT00453960

Sponsor

University of Messina

Status

Completed

Last Update Posted

Dec 19, 2008Estimated

Enrollment

59Actual

Phase

Phase 2

Conditions

Endometrial Hyperplasia

Interventions

Genivis
Norethisterone Acetate
placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Mar 28, 2007

First Submission Date that Met QC Criteria

Mar 28, 2007

First Posted Date

Mar 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2008

Last Update Posted Date

Dec 19, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Genistein	Experimental	Genistein 54 mg/day	Dietary Supplement: Genivis
Norethisterone Acetate	Active Comparator	Norethisterone Acetate 10mg/day	Drug: Norethisterone Acetate
Placebo	Placebo Comparator	Placebo tablets, daily	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genivis	Dietary Supplement	54 mg/day daily for 6 months	Genistein	Fosteum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery from endometrial hyperplasia		3-6 months

Secondary Outcomes

Measure	Description	Time Frame
Differential expression of ER-a and ER-b in endometrial specimens		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

44 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosario D'Anna, prof.	menopause centre	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"		Messina		98100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12466350	Result	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.

ID	Term
D004714	Endometrial Hyperplasia
D008796	Metrorrhagia

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D009640	Norethindrone
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids