The effect of myoinositol (MI) or metformin treatment on symptoms of polycystisk ovary syndrome (PCOS), including metabolism, menstrual pattern, quality of life and mental health.
Phase 1
- Conditions
- Polycystic ovarian syndrome (PCOS)Therapeutic area: Diseases [C] - Hormonal diseases [C19]MedDRA version: 19.1Level: LLTClassification code 10065161Term: Polycystic ovarian syndromeSystem Organ Class: 100000004872
- Registration Number
- EUCTR2016-004506-34-DK
- Lead Sponsor
- Odense Universitetshospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Age 18-50 years
Women with PCOS
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Postmenopausal
Dysregulated type 2 diabetes
Type 1 diabetes
Use of systemic hormonal contraceptives within 3 months
Use og metformin within 1 month
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of the dietary supplement myoinositol compared to the drug metformin in women with polycystic ovarian syndrome (PCOS). PCOS is characterized by irregular menstruations, high blood levels of male hormones, and increased male hair growth. Myoinositol and metformin decrease insulin resistance. The effect of myoinositol on symptoms of PCOS is not fully investigated and we investigate the effect compared to standard treatment with metformin. In the trial we investigate the effect on anthropometric measures, glucose metabolism, blood lipids, mental health, quality of life, sex hormones, menstrual pattern and side effects.;Secondary Objective: Not applicable;Primary end point(s): Insulin sensitivity estimated by homeostatic model assessment of insulin resistance (HOMA-IR);Timepoint(s) of evaluation of this end point: Baseline and after 6 months' treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Changes in anthropometric measures, glucose metabolism, blood lipids, mental health, quality of life, sex hormones, menstrual pattern and side effects.;Timepoint(s) of evaluation of this end point: Baseline and after 6 months' treatment