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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235924
Recruitment Status : Unknown
Verified October 2005 by Laboratoires Arkopharma.
Recruitment status was:  Active, not recruiting
First Posted : October 12, 2005
Last Update Posted : December 8, 2005
Information provided by:
Laboratoires Arkopharma

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.

Condition or disease Intervention/treatment Phase
Postmenopause Drug: soy isoflavone Phase 3

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.
Study Start Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Primary Outcome Measures :
  1. - Endometrial innocuity (endometrial biopsy result)

Secondary Outcome Measures :
  1. - Mammary innocuity (mammography results)
  2. - climacteric symptoms
  3. -Lipid profile
  4. -gynaecological and general safety

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235924

Sponsors and Collaborators
Laboratoires Arkopharma
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 Identifier: NCT00235924     History of Changes
Other Study ID Numbers: PHY04GE01
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: December 8, 2005
Last Verified: October 2005

Keywords provided by Laboratoires Arkopharma:
endometrial safety
breast innocuity assessment
hot flushes