Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Helena Teede
ORCID ID
Contact details
Monash Institute of Health Services Research
Monash Medical Centre
246 Clayton Road
Clayton
Melbourne
3168
Australia
+61 (0)3 9594 7545
helena.teede@med.monash.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PCOS
Study hypothesis
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
Ethics approval received from the Southern Health Human Ethics Committee in October 2002.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/10/2002
Overall trial end date
01/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
110
Participant 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
Recruitment start date
01/10/2002
Recruitment end date
01/06/2005
Locations
Countries of recruitment
Australia
Trial participating centre
Monash Institute of Health Services Research
Melbourne
3168
Australia
Sponsor information
Organisation
Southern Health (Australia)
Sponsor details
246 Clayton Road
Clayton
Melbourne
3168
Australia
+61 (0)3 9594 6666
malar.thiagarajan@southernhealth.org.au
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Pfizer (Australia) - competitive cardiovascular lipid grant 2003 and internal departmental 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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/17327307
Publication citations
-
Results
Meyer C, McGrath BP, Teede HJ, Effects of medical therapy on insulin resistance and the cardiovascular system in polycystic ovary syndrome., Diabetes Care, 2007, 30, 3, 471-478, doi: 10.2337/dc06-0618.