Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/03/2006
Date assigned
03/04/2006
Last edited
11/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.jeanhailes.org.au

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 measures

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

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

http://www.southernhealth.org.au

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17327307

Publication citations

  1. 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.

Additional files

Editorial Notes