NCT00453960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 19, 2008

Status Verified

December 1, 2008

Enrollment Period

1.8 years

First QC Date

March 28, 2007

Last Update Submit

December 18, 2008

Conditions

Endometrial Hyperplasia

Keywords

Endometrial hyperplasiaGenisteinIsoflavonesdysfunctional uterine bleeding

Outcome Measures

Primary Outcomes (1)

  • Recovery from endometrial hyperplasia

    3-6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (3)

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

GenivisDIETARY_SUPPLEMENT

54 mg/day daily for 6 months

Also known as: Fosteum
Genistein
Norethisterone AcetateDRUG

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

Norethisterone Acetate
placeboOTHER

tablets daily for 6 months

Placebo

Eligibility Criteria

Age44 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • All the other conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Messina, 98100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 12466350RESULT

MeSH Terms

Conditions

Endometrial HyperplasiaMetrorrhagia

Interventions

Norethindrone Acetate

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorethindroneNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Rosario D'Anna, prof.

    menopause centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 29, 2007

Study Start

January 1, 2007

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

December 19, 2008

Record last verified: 2008-12

Locations

IT(1)