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

Postmenopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00235924
• Other study ID #: PHY04GE01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: December 7, 2005
• Start date: June 2004

Study information

• Verified date: October 2005
• Source: Laboratoires Arkopharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• soy isoflavone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Arkopharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Endometrial innocuity (endometrial biopsy result)
Secondary	- Mammary innocuity (mammography results)
Secondary	- climacteric symptoms
Secondary	-Lipid profile
Secondary	-gynaecological and general safety