Biological variation of insulin resistance, testosterone and cardiovascular risk factors in women with polycystic ovary syndrome: modification with rimonabant compared to metformin

ISRCTN	ISRCTN75758249
DOI	https://doi.org/10.1186/ISRCTN75758249
Protocol serial number	R0391
Sponsor	Hull and East Yorkshire Hospitals NHS Trust (UK)
Funder	University of Hull (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Stephen Atkin
Scientific

Michael White Diabetes Centre
Hull Royal Infirmary
220-236 Analby Road
Hull
HU3 2JZ
United Kingdom

Phone	+44 (0)1482 6765
Email	s.l.atkin@hull.ac.uk

Primary study design	Interventional
Study design	Randomised, open-label, parallel study.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Ethics approval(s)	Ethics approval received from Hull and East Riding Local Research Ethics Committee on the 19th December 2006 (ref: 06/Q1104/115).
Health condition(s) or problem(s) studied	PolyCystic Ovary Syndrome (PCOS)
Intervention	Rimonabant 20 mg (oral) daily or metformin 500 mg (oral) three times a day (tds) for 3 months.
Intervention type	Other
Primary outcome measure(s)	The following will be assessed at 3 months: 1. The HOMeostasis model Assessment of Insulin Resistance (HOMA-IR) 2. Testosterone
Key secondary outcome measure(s)	The following will be assessed at 3 months: 1. Waist cirumference 2. Free androgen index
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	20
Key inclusion criteria	1. Polycystic ovarian syndrome 2. Body Mass Index (BMI) greater than 30 kg/m^2
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	01/01/2008

Michael White Diabetes Centre

Hull
HU3 2JZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No