NCT00235924

Brief Summary

The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

December 8, 2005

Status Verified

October 1, 2005

First QC Date

October 7, 2005

Last Update Submit

December 7, 2005

Conditions

Postmenopause

Keywords

menopauseisoflavoneendometrial safetybreast innocuity assessmenthot flushes

Outcome Measures

Primary Outcomes (1)

  • - Endometrial innocuity (endometrial biopsy result)

Secondary Outcomes (4)

  • - Mammary innocuity (mammography results)

  • - climacteric symptoms

  • -Lipid profile

  • -gynaecological and general safety

Interventions

soy isoflavoneDRUG

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not hysterectomised women
  • Post menopausal (at least 2 years)
  • FSH superior to 30 UI/l and oestradiol inferior to 35 ng/ml
  • Presenting with hot flushes (but not incapacitating) or climacteric symptoms

You may not qualify if:

  • History of endometrial hyperplasia
  • Known hormono-dependent malignant tumours
  • BMI superior to 30 Kg/m2
  • Uncontrolled arterial hypertension
  • Known renal or liver insufficiency
  • Recent or evolutive thromboembolic disease
  • Unexplained bleeding, endometrial polyps, submucous myomas, active endometriosis, ovarian cyst superior to 30 mm
  • Local hormonal treatment, raloxifene,tibolone within the 3 months before V1 and during the study
  • HRT and DHEA within the 3 months before V2 and during the study
  • isoflavones within the 2 months before V2 and during the study
  • clonidine, beta-alanine, veralipride within 1 month before V1 and during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hot Flashes

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • Pierre MARES, Professor

    Hospital of Caremeau, Nîmes, FRANCE

    STUDY CHAIR

  • Santiago PALACIOS, Professor

    Instituto Palacios, Madrid, SPAIN

    PRINCIPAL INVESTIGATOR

  • Bruno PORNEL, Doctor

    Brussels Menopause Center, Bruxelles, BELGIUM

    PRINCIPAL INVESTIGATOR

  • John EDEN, Professor

    Sydney Menopause Center, Sydney, AUSTRALIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

June 1, 2004

Last Updated

December 8, 2005

Record last verified: 2005-10