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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2005 by Laboratoires Arkopharma.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Laboratoires Arkopharma

ClinicalTrials.gov Identifier:

NCT00235924

First received: October 7, 2005

Last updated: December 7, 2005

Last verified: October 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

October 7, 2005

Last Updated Date

December 7, 2005

Start Date ^ICMJE

June 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

- Endometrial innocuity (endometrial biopsy result)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00235924 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Postmenopause

Intervention ^ICMJE

Drug: soy isoflavone

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

300

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00235924

Other Study ID Numbers ^ICMJE

PHY04GE01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Laboratoires Arkopharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Laboratoires Arkopharma

Verification Date

October 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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