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| Biological variation of insulin resistance, testosterone and cardiovascular risk factors in women with polycystic ovary syndrome: modification with rimonabant compared to metformin |
| Source of record | UK Trials |
| ISRCTN | ISRCTN75758249 |
| Date ISRCTN assigned | 31/10/2007 |
| Local reference number(s) | R0391 |
| Public title | Biological variation of insulin resistance, testosterone and cardiovascular risk factors in women with polycystic ovary syndrome: modification with rimonabant compared to metformin |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | PolyCystic Ovary Syndrome (PCOS) |
| Study hypothesis | 1. To show that rimonabant treatment is superior to metformin in reducing mean insulin resistance, high androgen levels and cardiovascular risk indices in women with PolyCystic Ovarian Syndrome (PCOS) 2. To show that rimonabant treatment is superior to metformin in reducing the fluctuations in biological variation of insulin resistance in PCOS |
| Design/methodology | Randomised, open-label, parallel study. |
| Research ethics review | Ethics approval received from Hull and East Riding Local Research Ethics Committee on the 19th December 2006 (ref: 06/Q1104/115). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Polycystic ovarian syndrome 2. Body Mass Index (BMI) greater than 30 kg/m^2 |
| Participants - exclusion criteria | 1. Patient should not be on any drugs 2. Unwilling for General Practitioner (GP) to be informed 3. Diabetic patients 4. Uncompensated hypothyroidism 5. Patients not on barrier contraception 6. History of psychiatric disorder or severe depression 7. Chronic renal failure |
| Patient information material | |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/01/2008 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | Rimonabant 20 mg (oral) daily or metformin 500 mg (oral) three times a day (tds) for 3 months. |
| Primary outcome measure(s) | The following will be assessed at 3 months: 1. The HOMeostasis model Assessment of Insulin Resistance (HOMA-IR) 2. Testosterone |
| Secondary outcome measure(s) | The following will be assessed at 3 months: 1. Waist cirumference 2. Free androgen index |
| Sources of funding | University of Hull (UK) |
| Sponsor name | Hull and East Yorkshire Hospitals NHS Trust (UK) |
| Sponsor details | c/o Mrs Nina Dunham R&D admin portacabin Castle Hill Hospital Castle Road Cottingham, East Yorkshire Hull United Kingdom HU16 5JQ |
| Sponsor website | http://www.hey.nhs.uk/ |
| Contact name | Prof Stephen Atkin |
| Contact details | Michael White Diabetes Centre Hull Royal Infirmary 220-236 Analby Road Hull United Kingdom HU3 2JZ |
| Contact telephone | +44 (0)1482 6765 |
| Contact fax | +44 (0)1482 6770 |
| Contact email | s.l.atkin@hull.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN75758249 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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