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

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: Postmenopause
• Intervention / Treatment: Drug: soy isoflavone

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

Eligibility Criteria

• Ages Eligible for Study: 41 years to 61 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

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

• 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

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: menopause; hot flushes; isoflavone; endometrial safety; breast innocuity assessment
• Other Study ID Numbers: PHY04GE01