Protocol for a pilot study examining the impact of Metformin use on serum testosterone levels in postmenopausal women - PILOTINA

Conditions: HYPERANDROGENISM
MedDRA version: 6.1Level: HLGTClassification code 10052547

Registration Number: EUCTR2006-000285-36-IT

Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Postmenopausal women defined as women with no menstrual period for at least 12 months before enrollment in the study in the age range of 55 to 74 with elevated levels of serum testosterone 8805;1.6 nmol/L without clinical evidence of cancer at the mammographic examination.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

a Women with previous history of breast cancer, or with suspicious cancer lesions b Women with elevated serum creatinine levels 8805;200mmol/L c Women currently receiving hormone replacement therapy d Women with a diagnosis of type 1 and type 2 diabetes e Women diagnosed with the following cardiovascular diseases Coronary artery disease, history of myocardial infarction, hypertension, heart failure, stroke

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: b Whether metformin 850mg/twice a day decreases serum testosterone levels in postmenopausal women women without menstrual cycles for at least 12 months before the enrollment in the study between 55 to 74 years of age.;Secondary Objective: a Whether a large randomized controlled clinical trial to prevent breast cancer occurrence with metformin in healthy postmenopausal women at high risk is feasible with special regard to whether women agree to participate and can be recruited over short periods of time.;Primary end point(s): Reduction of 22 in the mean level of serum testosteron

Secondary Outcome Measures