se of Metformin to reduce serum level of Testosterone and improve the metabolic picture in women treated for breast cancer - Metformin and serum Testosterone in women with breast cancer
- Conditions
- Menopausal women on treatment for BC, with higher risk of recurrence due to augmented level of TMedDRA version: 6.1Level: PTClassification code 10006187
- Registration Number
- EUCTR2006-006236-22-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Women with previous surgery for BC, in spontaneous menopause, aged less than 70 years, with serum T level above the median, in one of the following conditions (characterized by endocrine and metabolic stabilization): 1) At least 6 months from surgery in absence of systemic treatment; 2) In therapy with Tamoxifen since at least 6 months with the perspective of prosecute it for at least another year; 3) At least 6 months from the end of chemiotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Previous cardiovascular disease (myocardial infarction, coronary disease, stroke); diabetes ID and NID; use of statins; cotraindications to the use of Metformin, in particular the conditions at risk of lactic acidosis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method