Polycystic ovary syndrome Nutritional, Metabolic, Endocrine Ovarian dysfunction
Conditions
Interventions
The two treatment arms are metformin and placebo. During the study phase, patients received consecutive daily doses of metformin for 12 weeks (84 days) followed by placebo or placebo followed by metfo
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. From the Endocrinology clinics at the University Hospital of Wales 2. Diagnosed with PCOS, based on androgen excess (clinical symptoms of hyperandrogenism and/or elevated testosterone) with ovulatory dysfunction (fewer than six menstrual cycles per year), supported by ovarian ultrasound where available 3. Congenital adrenal hyperplasia, Cushings syndrome, androgen-secreting neoplasms, hyperprolactinaemia and thyroid disease excluded by biochemical testing 4. Aged between 18 and 35 years
Exclusion criteria
Exclusion criteria: 1. Pregnant 2. Breastfeeding 3. History of current or previous use (within 6 months) of oral contraceptives, anti-diabetics or anti-androgens 4. Contraindications to metformin therapy including renal or hepatic impairment, ketoacidosis, or conditions where tissue hypoxia is likely (e.g. sepsis, respiratory failure, recent myocardial infarction) 5. History of hypertension or diabetes 6. Able to use barrier methods of contraception if sexually active. In addition, pregnancy tests were performed at each study visit and patients were withdrawn from the study in the event of confirmed pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in measures of arterial stiffness (pulse wave velocity and augmentation index as measured by pulse wave analysis post-salbutamol versus post-GTN) from baseline, recorded at enrolment and then repeated at 12 weeks, 20 weeks and 32 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in testosterone, plasminogen activator inhibitor-1 (PAI-1), endothelin-1 (ET-1) and high sensitivity C-reactive protein (hsCRP) 2. Measures of insulin resistance 3. Lipid profile Recorded at enrolment and then repeated at 12 weeks, 20 weeks and 32 weeks. | — |
Countries
United Kingdom
Outcome results
None listed