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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000285-36-IT

Enrollment

100

Registered

2006-04-21

Start date

2006-04-01

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

HYPERANDROGENISM MedDRA version: 6.1 Level: HLGT Classification code 10052547

Interventions

Trade Name: METFORAL 850MG 30CPR RIV. Pharmaceutical Form: Tablet INN or Proposed INN: Metformin CAS Number: 1115-70-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

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