The effects of medical therapy on insulin resistance and the cardiovascular system in PolyCystic Ovarian Syndrome

ISRCTN	ISRCTN51367236
DOI	https://doi.org/10.1186/ISRCTN51367236
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Helena Teede
Scientific

Monash Institute of Health Services Research
Monash Medical Centre
246 Clayton Road
Clayton
Melbourne
3168
Australia

Phone	+61 (0)3 9594 7545
Email	helena.teede@med.monash.edu.au

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	PCOS
Study objectives	Women with polycystic ovarian syndrome (PCOS) and insulin resistance will have equivalent efficacy with metformin and both high- and low-dose oral contraceptives, yet the metabolic effects of the therapy will differ with metformin and the lower dose oral contraceptive pill (OCP) having relatively more favorable effects on insulin resistance and metabolic and cardiovascular parameters.
Ethics approval(s)	Ethics approval received from the Southern Health Human Ethics Committee in October 2002.
Health condition(s) or problem(s) studied	Polycystic ovarian syndrome
Intervention	Patients are randomised to receive one of the following interventions: 1. Control group: higher dose OCP - 35 mcg ethinyl oestradiol (EE), 2 mg cyproterone acetate 2. Metformin - 1 g greater than twice daily (bd) 3. Low dose OCP - 20 mcg EE, 100 mcg levonorgestrel and 50 mg aldactone bd
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ethinyl oestradiol (EE), cyproterone acetate, metformin, levonorgestrel and aldactone
Primary outcome measure	Effects on insulin resistance
Secondary outcome measures	1. Clinical symptom improvement 2. Arterial function
Overall study start date	01/10/2002
Completion date	01/06/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	110
Key inclusion criteria	1. Overweight women (body mass index [BMI] greater than 27 kg/m^2) 2. Aged 18 - 40 years with PCOS diagnosed from a history of perimenarchal onset of irregular cycles (less than 21 days or greater than 35 days) plus clinical manifestations of hyperandrogenism (hirsutism, acne) or biochemical hyperandrogenism with elevation of at least one circulating ovarian androgen (1990 National Institute of Health [NIH] criteria)
Key exclusion criteria	1. BMI less than 27 kg/m^2 2. Other concurrent medical conditions 3. Ongoing use of the OCP 4. Pregnancy or desire for pregnancy 4. Secondary causes of amenorrhoea and hyperandrogenism
Date of first enrolment	01/10/2002
Date of final enrolment	01/06/2005

Monash Institute of Health Services Research

Melbourne
3168
Australia

Southern Health (Australia)
Government

246 Clayton Road
Clayton
Melbourne
3168
Australia

Phone	+61 (0)3 9594 6666
Email	malar.thiagarajan@southernhealth.org.au
Website	http://www.southernhealth.org.au

Industry

Pfizer (Australia) - competitive cardiovascular lipid grant 2003 and internal departmental fund

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/03/2007		Yes	No