Atorvastatin in polycystic ovary syndrome (PCOS)

ISRCTN	ISRCTN24474824
DOI	https://doi.org/10.1186/ISRCTN24474824
Secondary identifying numbers	R0061

Submission date: 03/04/2008
Registration date: 09/05/2008
Last edited: 15/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stephen Atkin
Scientific

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

Study information

Study design	A double blind placebo controlled parallel study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of atorvastatin on the metabolic syndrome of polycystic ovary syndrome
Study acronym	PAT
Study objectives	Atorvastatin improves metabolic syndrome and hyperandrogenaemia in patients with polycystic ovary syndrome (PCOS) compared to placebo.
Ethics approval(s)	Ethics approval received from South Humberside Local Research Ethics Committee on the 5th September 2004 (ref: 04/Q1105/60).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Atorvastatin
Primary outcome measure	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 study start date	13/07/2006
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Female
Target number of participants	40
Total final enrolment	40
Key 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
Key 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
Date of first enrolment	13/07/2006
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Michael White Diabetes Centre

Hull
HU3 2RZ
United Kingdom

Sponsor information

Hull and East Yorkshire Hospital NHS Trust (UK)
Hospital/treatment centre

c/o Mrs Nina Dunham
Research and Development Manager
Research and Development Admin Portacabin
Castle Hill Hospital, Castle Road
Cottingham
Hull
HU16 5JQ
England
United Kingdom

Website	http://www.hey.nhs.uk/
"ROR"	https://ror.org/01b11x021

Funders

Funder type

University/education

University of Hull (UK) - Diabetes Endowment Fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No
Results article	results	25/06/2019	15/07/2019	Yes	No

Editorial Notes

15/07/2019: Publication reference and total final enrolment added.