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Trial registered on ANZCTR


Trial ID
ACTRN12605000219684
Ethics application status
Approved
Date submitted
23/08/2005
Date registered
26/08/2005
Date last updated
26/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised controlled trial comparing the effects of metformin with the 20 microgram ethinyl estradiol oral contraceptive pill on the hormonal and metabolic profiles in women with polycystic ovarian syndrome.
Scientific title
A prospective randomised controlled trial comparing the effects of metformin with the 20 microgram ethinyl estradiol oral contraceptive pill on the hormonal and metabolic profiles in women with polycystic ovarian syndrome.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 302 0
Condition category
Condition code
Metabolic and Endocrine 345 345 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is metformin for 6 months.
Intervention code [1] 235 0
Treatment: Drugs
Comparator / control treatment
Control is the microgram oral contraceptive pill for 6 months.
Control group
Active

Outcomes
Primary outcome [1] 400 0
Fasting insulin & glucose
Timepoint [1] 400 0
At baseline (week 0), 3 months, 6 months and 9 months (i.e. 3 months after stopping the intervention)
Secondary outcome [1] 870 0
Clinical (weight, BMI, WHR, and BP, menstrual cyclicity).
Timepoint [1] 870 0
Secondary outcome [2] 871 0
Hormonal (serum levels of FSH, LH, T, DHEAS, and SHBG).
Timepoint [2] 871 0
Secondary outcome [3] 872 0
Other metabolic (fasting lipids) and radiological (body composition on DEXA) and timing.
Timepoint [3] 872 0
At 3, 6, and 9 months.

Eligibility
Key inclusion criteria
1. Obese (BMI > 28kg/m2) or non-obese (BMI < 28kg/m2) PCOS as defined above2. Amenorrhea or oligo-amenorrhea3. No contraindications to OCP a) History of, or current, thrombophlebitis, thromboembolic disorders and conditions which predispose to such diseases including venous thromboembolism. b) History of, or existing, cerebral vascular/ coronary artery disease c) Known or suspected carcinoma of the breast or the endometrium or a history of these d) Impaired liver function or active liver disease e) Undiagnosed abnormal vaginal bleeding f) Known or suspected pregnancy g) Women older than 35yrs age with hypertension, diabetes, or who smoke 4. No contraindications to metformin a) hypersensitivity to metformin or other biguanides b) diminished renal function c) cardiovascular disease (e.g. coronary insufficiency, myocardial infarction) d) severe hepatic dysfunction e) pancreatitis f) excessive alcohol intake g) concomitant use of diuretics5. No medications (including hormones) known to alter gonadal function, carbohydrate metabolism, or lipoprotein metabolism taken during the two months preceding the study6. Each woman to give informed consent to participate in the study.
Minimum age
Not stated
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diabetes mellitis2. Wishing to conceive.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 405 0
Hospital
Name [1] 405 0
Royal Hospital for Wormen
Address [1] 405 0
Country [1] 405 0
Primary sponsor type
Individual
Name
Michael Costello
Address
Country
Secondary sponsor category [1] 328 0
None
Name [1] 328 0
Nil
Address [1] 328 0
Country [1] 328 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35435 0
Address 35435 0
Country 35435 0
Phone 35435 0
Fax 35435 0
Email 35435 0
Contact person for public queries
Name 9424 0
Michael Costello
Address 9424 0
Royal Hospital for Women
Barker St
Randwick NSW 2035
Country 9424 0
Australia
Phone 9424 0
+61 2 93826677
Fax 9424 0
Email 9424 0
mfcostello@unsw.edu.au
Contact person for scientific queries
Name 352 0
Michael Costello
Address 352 0
Royal Hospital for Women
Barker St
Randwick NSW 2035
Country 352 0
Australia
Phone 352 0
+61 2 93826677
Fax 352 0
Email 352 0
mfcostello@unsw.edu.au