Overview

This trial is active, not recruiting.

Condition postmenopause
Treatment soy isoflavone
Phase phase 3
Sponsor Laboratoires Arkopharma
Start date June 2004
Trial size 300 participants
Trial identifier NCT00235924, PHY04GE01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
- Endometrial innocuity (endometrial biopsy result)
time frame:

Secondary Outcomes

Measure
- Mammary innocuity (mammography results)
time frame:
- climacteric symptoms
time frame:
-Lipid profile
time frame:
-gynaecological and general safety
time frame:

Eligibility Criteria

Female participants from 45 years up to 65 years old.

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.

Additional Information

Official title Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.
Principal investigator Santiago PALACIOS, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by Laboratoires Arkopharma.