Polycystic Ovary Syndrome - Improving Outcomes
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|ClinicalTrials.gov Identifier: NCT01504321|
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : January 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: Moxonidine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve Outcomes|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||December 2015|
|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
- Microneurography [ Time Frame: 3 months ]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 ]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 ]A standard 75g glucose tolerance test will be performed. Venous blood will be taken before and 2 hours after the glucose drink was given.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504321
|Heart Centre, Alfred Hospital|
|Prahran, Victoria, Australia, 3004|
|Principal Investigator:||Gavin Lambert, Dr||BakerIDI Heart and Diabetes Institute|