Polycystic ovary syndrome is one of the most common endocrine disorders, affecting approximately 10% of women of reproductive age, associated with hyperandrogenaemia and menstrual dysfunction. The aim of the study is to examine the effects of the insulin sensitizing drug metformin on ovarian function and ovulation rate in women with PCOS. MedDRA version: 9.1 Level: LLT Classification code 10014695 Term: Endocrine disorder
Conditions
Sponsors
Universitätsfrauenklinik Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: hyperandrogenaemia age: 18-40 years pregnancy excluded no renal or liver diseases written informed consent 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: diabetes I + II pregnancy taking drugs, which could falsify the results or could lead to unwanted effects of metformin side effects like lactate acidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: normalisation of hyperandrogenaemia in PCOS women;Secondary Objective: improvement of fertility;Primary end point(s): normalisation of Testosteron levels increase of ovulation rates | — |
Countries
Austria
Outcome results
None listed