FindTrial
Sign In

Use 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

Use 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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006236-22-IT
Enrollment
Unknown
Registered
2010-06-17
Start date
2007-01-31
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal women on treatment for BC, with higher risk of recurrence due to augmented level of T MedDRA version: 6.1 Level: PT Classification code 10006187

Interventions

Trade Name: METFORMINA MERCK Pharmaceutical Form: Tablet INN or Proposed INN: Metformin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-

Sponsors

AZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Relatively high level of Testosterone, due to insulin resistance, are asociated with higher risk of breast cancer (BC) and even of recurrences of BC. The main objective is to define the smallest dose of Metformin able to reduce augmented serum level of T and to modify other metabolic parameters in menopausal women on treatment for BC (randomised comparison of two doses);Secondary Objective: To define the toleralibity of Metformin 1000 - 1500 mg/d in menopausal women on treatment for BC;Primary end point(s): To define the smallest dose of Metformin able to reduce augmented serum level of Testosterone in women on treatment for breast cancer—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026