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 |
| Protocol serial number | N/A |
| Sponsor | Southern Health (Australia) |
| Funder | Pfizer (Australia) - competitive cardiovascular lipid grant 2003 and internal departmental fund |
- Submission date
- 28/03/2006
- Registration date
- 03/04/2006
- Last edited
- 11/04/2008
- 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 Helena Teede
Scientific
Scientific
Monash Institute of Health Services Research
Monash Medical Centre
246 Clayton Road
Clayton
Melbourne
3168
Australia
| Phone | +61 (0)3 9594 7545 |
|---|---|
| helena.teede@med.monash.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ethinyl oestradiol (EE), cyproterone acetate, metformin, levonorgestrel and aldactone |
| Primary outcome measure(s) |
Effects on insulin resistance |
| Key secondary outcome measure(s) |
1. Clinical symptom improvement |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Australia
Study participating centre
Monash Institute of Health Services Research
Melbourne
3168
Australia
3168
Australia
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 | 01/03/2007 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
