Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/10/2007
Date assigned
31/10/2007
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hey.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes