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
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00235924     History of Changes
Other Study ID Numbers: PHY04GE01
Study First Received: October 7, 2005
Last Updated: December 7, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

ClinicalTrials.gov processed this record on July 22, 2014