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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01504321




Registration number
NCT01504321
Ethics application status
Date submitted
2/01/2012
Date registered
5/01/2012
Date last updated
2/11/2018

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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Gender
Females
Can healthy volunteers participate?
Yes
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
Treatment
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
VIC
Recruitment hospital [1] 0 0
Heart Centre, Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
3004 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
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
syndrome.
Trial website
https://clinicaltrials.gov/show/NCT01504321
Trial related presentations / publications
Public notes

Contacts
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