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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Polycystic Ovary Syndrome - Improving Outcomes
Scientific title
Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve Outcomes
Secondary ID [1] 0 0
Human Neuro -PCOS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Moxonidine
Treatment: Drugs - Placebo

Active Comparator: Active -

Placebo Comparator: Placebo -

Treatment: Drugs: Moxonidine
0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months

Treatment: Drugs: Placebo
Encapsulated lactose powder

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Microneurography - Microneurography is a technique developed to measure the sympathetic activitiy directly from the peroneal nerve. Microneurography will be performed at baseline visit and at 3 months follow up visit.
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Blood biochemistry measurement - To assess the metabolic function of the participants we will be drawing fasting blood samples for biochemical analysis. These test will be performed at baseline and 3 months follow up visit
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Oral glucose tolerance test - A standard 75g glucose tolerance test will be performed. Venous blood will be taken before and 2 hours after the glucose drink was given.
Timepoint [2] 0 0
3 months

Key inclusion criteria
- Overweight and class I obese pre-menopausal women

- Diagnosis of PCOS by Rotterdam criteria
Minimum age
18 Years
Maximum age
45 Years
Can healthy volunteers participate?
Key exclusion criteria
- Any current medication

- pregnancy or the desire to become pregnant

- BMI > 35

- a history of type I diabetes, secondary hypertension not due to PCOS

- cardiovascular, cerebrovascular, liver or thyroid disease

- severe mental illness.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Heart Centre, Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
3004 - Prahran

Funding & Sponsors
Primary sponsor type
Baker IDI Heart and Diabetes Institute

Ethics approval
Ethics application status

Brief summary
Polycystic ovary syndrome affects a striking 9-18% of Australian reproductive aged women and
has been associated with a number of metabolic abnormalities.

Given the strong correlation between metabolic abnormalities and increased sympathetic
activity, we hypothesise that reducing this activity using medication (moxonidine) can help
improve the metabolic abnormalities, and therefore improve outcomes in polycystic ovary
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Gavin Lambert, Dr
Address 0 0
BakerIDI Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications