Polycystic Ovary Syndrome - Improving Outcomes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve Outcomes|
- Microneurography [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Blood biochemistry measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]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
- Oral glucose tolerance test [ Time Frame: 3 months ] [ Designated as safety issue: No ]A standard 75g glucose tolerance test will be performed. Venous blood will be taken before and 2 hours after the glucose drink was given.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Active||
0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months
|Placebo Comparator: Placebo||
Encapsulated lactose powder
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504321
|Contact: Gavin Lambert, Dr||03 8532 firstname.lastname@example.org|
|Contact: Carolina Sari, Miss||03 8532 email@example.com|
|Heart Centre, Alfred Hospital||Recruiting|
|Prahran, Victoria, Australia, 3004|
|Principal Investigator:||Gavin Lambert, Dr||BakerIDI Heart and Diabetes Institute|