Clinical trial NCT00235924: Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women
Official title: Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postmenopause
Keywords: menopause
isoflavone
endometrial safety
breast innocuity assessment
hot flushes
Lead sponsor: Laboratoires Arkopharma
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: - Endometrial innocuity (endometrial biopsy result)
Secondary outcomes:
measure: - Mammary innocuity (mammography results)
measure: - climacteric symptoms
measure: -Lipid profile
measure: -gynaecological and general safety
Other outcomes:
Locations:
Study officials:
affiliation: Hospital of Caremeau, Nîmes, FRANCE
name: Pierre MARES, Professor
role: STUDY_CHAIR
affiliation: Instituto Palacios, Madrid, SPAIN
name: Santiago PALACIOS, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Brussels Menopause Center, Bruxelles, BELGIUM
name: Bruno PORNEL, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sydney Menopause Center, Sydney, AUSTRALIA
name: John EDEN, Professor
role: PRINCIPAL_INVESTIGATOR
References: