Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/04/2008
Date assigned
09/05/2008
Last edited
28/03/2012
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 2RZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R0061

Study information

Scientific title

Effect of atorvastatin on the metabolic syndrome of polycystic ovary syndrome

Acronym

PAT

Study hypothesis

Atorvastatin improves metabolic syndrome and hyperandrogenaemia in patients with polycystic ovary syndrome (PCOS) compared to placebo.

Ethics approval

Ethics approval received from South Humberside Local Research Ethics Committee on the 5th September 2004 (ref: 04/Q1105/60).

Study design

A double blind placebo controlled parallel study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Polycystic ovary syndrome (PCOS)

Intervention

40 patients with polycystic ovary syndrome will be randomised to:
1. 20 patients treated with atorvastatin 20 mg
2. 20 patients treated placebo

The total duration of the study and follow up is three months.

Intervention type

Drug

Phase

Not Specified

Drug names

Atorvastatin

Primary outcome measures

Improvement in biochemical hyperandrogenaemia, measured at baseline and after three months.

Secondary outcome measures

Improvement in insulin resistance, measured at baseline and after three months.

Overall trial start date

13/07/2006

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis of PCOS was based on Rotterdam criteria
2. Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, and androgen secreting tumours excluded by appropriate tests
3. Subjects were advised not to alter their usual dietary and exercise habits
4. Females aged 18 - 40 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. No concurrent illness
2. Patients not wishing to allow disclosure to their GPs
3. Patients not on barrier or oral progesterone contraception

Recruitment start date

13/07/2006

Recruitment end date

01/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Michael White Diabetes Centre
Hull
HU3 2RZ
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospital NHS Trust (UK)

Sponsor details

c/o Mrs Nina Dunham
Research and Development Manager
Research and Development Admin Portacabin
Castle Hill Hospital
Castle Road
Cottingham
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) - Diabetes Endowment Fund

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21972424

Publication citations

  1. Results

    Sathyapalan T, Smith KA, Coady AM, Kilpatrick ES, Atkin SL, Atorvastatin therapy decreases androstenedione and dehydroepiandrosterone sulphate concentrations in patients with polycystic ovary syndrome: randomized controlled study., Ann. Clin. Biochem., 2012, 49, Pt 1, 80-85, doi: 10.1258/acb.2011.011071.

Additional files

Editorial Notes