Atorvastatin in polycystic ovary syndrome (PCOS)
| ISRCTN | ISRCTN24474824 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24474824 |
| Protocol serial number | R0061 |
| Sponsor | Hull and East Yorkshire Hospital NHS Trust (UK) |
| Funder | University of Hull (UK) - Diabetes Endowment Fund |
- 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
Scientific
Michael White Diabetes Centre
Hull Royal Infirmary
220 - 236 Analby Road
Hull
HU3 2RZ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A double blind placebo controlled parallel study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atorvastatin |
| Primary outcome measure(s) |
Improvement in biochemical hyperandrogenaemia, measured at baseline and after three months. |
| Key secondary outcome measure(s) |
Improvement in insulin resistance, measured at baseline and after three months. |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
Michael White Diabetes Centre
Hull
HU3 2RZ
United Kingdom
HU3 2RZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/07/2019: Publication reference and total final enrolment added.
