Contact information
Type
Scientific
Primary contact
Prof Stephen Atkin
ORCID ID
Contact details
Michael White Diabetes Centre
Hull Royal Infirmary
220-236 Analby Road
Hull
HU3 2JZ
United Kingdom
+44 (0)1482 6765
s.l.atkin@hull.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R0391
Study information
Scientific title
Acronym
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
Ethics approval
Ethics approval received from Hull and East Riding Local Research Ethics Committee on the 19th December 2006 (ref: 06/Q1104/115).
Study design
Randomised, open-label, parallel study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
The following will be assessed at 3 months:
1. The HOMeostasis model Assessment of Insulin Resistance (HOMA-IR)
2. Testosterone
Secondary outcome measures
The following will be assessed at 3 months:
1. Waist cirumference
2. Free androgen index
Overall trial start date
01/09/2006
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Polycystic ovarian syndrome
2. Body Mass Index (BMI) greater than 30 kg/m^2
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
20
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Michael White Diabetes Centre
Hull
HU3 2JZ
United Kingdom
Sponsor information
Organisation
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
HU16 5JQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
University/education
Funder name
University of Hull (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19128368
Publication citations
-
Results
Sathyapalan T, Cho LW, Kilpatrick ES, Coady AM, Atkin SL, Metformin maintains the weight loss and metabolic benefits following rimonabant treatment in obese women with polycystic ovary syndrome (PCOS)., Clin. Endocrinol. (Oxf), 2009, 70, 1, 124-128, doi: 10.1111/j.1365-2265.2008.03345.x.