Metformin-Wirkung am Ovar bei PCOS (MAO-Studie) - eine Pilotstudie
Phase 1
- Conditions
- 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: 9.1Level: LLTClassification code 10014695Term: Endocrine disorder
- Registration Number
- EUCTR2006-001911-31-AT
- Lead Sponsor
- niversitätsfrauenklinik Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 20
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
diabetes I + II
pregnancy
taking drugs, which could falsify the results or could lead to unwanted effects of metformin
side effects like lactate acidosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: normalisation of hyperandrogenaemia in PCOS women;Secondary Objective: improvement of fertility;Primary end point(s): normalisation of Testosteron levels<br>increase of ovulation rates
- Secondary Outcome Measures
Name Time Method