Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women

December 7, 2005 updated by: Laboratoires Arkopharma

Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is an international multicentre open study, assessing the innocuity on breast and endometrium of a 70 mg daily dose of isoflavones standardized extract (Phytosoya).

This study follows the European guidelines :one-year treatment duration, biopsy and mammography performed at the beginning and at the end of the trial, recruitment of enough subjects in order to have 300 patients with an evaluable biopsy after one year of treatment.

After 3 weeks of screening phase, the patients will be taken Phytosoya during 52 weeks. At the end of the first year of treatment, an endometrial biopsy, an endovaginal ultrasonography, a mammography, breast ultrasounds, a clinical examination and a biological assessment will be performed.

In addition, it will be proposed to patients to continue treatment during 2 additional years. At the end of the third year,the same examinations will be performed.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Endometrial innocuity (endometrial biopsy result)

Secondary Outcome Measures

Outcome Measure
- Mammary innocuity (mammography results)
- climacteric symptoms
-Lipid profile
-gynaecological and general safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Arkopharma

Investigators

  • Study Chair: Pierre MARES, Professor, Hospital of Caremeau, Nîmes, FRANCE
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

December 8, 2005

Last Update Submitted That Met QC Criteria

December 7, 2005

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHY04GE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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