Polycystic Ovary Syndrome
Conditions
Interventions
Trade Name: Metformin Hydrochloride
(Glucophage)
Product Name: Metformin
Product Code: not applicable
Pharmaceutical Form: Tablet
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of polycystic ovary syndrome. This will be based on evidence of androgen excess (clinical symptoms of hyperandrogenism and/or elevated testosterone) with ovulatory dysfunction (fewer than 6 menstrual cycles per year), supported by ovarian ultrasound where available. Congenital adrenal hyperplasia, Cushing’s syndrome, androgen-secreting neoplasms, hyperprolactinaemia and thyroid disease will be excluded by biochemical testing. 2. Patients will be aged between 18 and 30 years. 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: 1. Pregnancy or the intention to become pregnant during the course of this trial. 2. Breastfeeding. 3. A history of current or previous use (within 6 months) of oral contraceptives, antidiabetics or antiandrogens. 4. Medical history of diabetes or hypertension. 5. Contraindications to metformin therapy including renal or hepatic impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether metformin therapy improves endothelial function and arterial compliance in young women with polycystic ovary syndrome and to establish whether the degree of insulin resistance following metformin treatment is the major determinant of improvement in endothelial response in young women with polycystic ovary syndrome.;Secondary Objective: To determine whether treatment with metformin reduces metabolic risk by measuring its effect on insulin sensitivity, lipid profiles and markers of inflammation in young women with polycystic ovary syndrome.;Primary end point(s): The primary end-points of this study will be changes in endothelial function and arterial stiffness i.e. changes in pulse wave velocity and augmentation index (as measured by pulse wave analysis post-salbutamol versus post-GTN) from baseline. Secondary end-points will include changes in testosterone, PAI-1, ET-1, hsCRP, measures of insulin resistance and lipid profile. | — |
Countries
United Kingdom
Outcome results
None listed