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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Blood biochemistry measurement
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Oral glucose tolerance test
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
Sex
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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
42
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 Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01504321