Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women - Full Text View

Sponsored by:	Laboratoires Arkopharma
Information provided by:	Laboratoires Arkopharma
ClinicalTrials.gov Identifier:	NCT00235924

Purpose

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

Condition	Intervention	Phase
Postmenopause	Drug: soy isoflavone	Phase III

MedlinePlus related topics: Menopause

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.

Further study details as provided by Laboratoires Arkopharma:

Primary Outcome Measures:

- Endometrial innocuity (endometrial biopsy result)

Secondary Outcome Measures:

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

Estimated Enrollment:	300
Study Start Date:	June 2004

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.

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235924

Sponsors and Collaborators

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

More Information

Study ID Numbers:	PHY04GE01
Study First Received:	October 7, 2005
Last Updated:	December 7, 2005
ClinicalTrials.gov Identifier:	NCT00235924
Health Authority:	France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Laboratoires Arkopharma:

menopause
isoflavone
endometrial safety
breast innocuity assessment
hot flushes

Study placed in the following topic categories:

Hot Flashes
Flushing
Menopause

ClinicalTrials.gov processed this record on January 16, 2009