Polycystic Ovary Syndrome - Improving Outcomes

November 1, 2018 updated by: Markus Schlaich, Baker Heart and Diabetes Institute

Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Prahran, Victoria, Australia, 3004
        • Heart Centre, Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Overweight and class I obese pre-menopausal women
  • Diagnosis of PCOS by Rotterdam criteria

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Encapsulated lactose powder
Active Comparator: Active
Drug: Moxonidine
0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baker Heart and Diabetes Institute

Investigators

  • Principal Investigator: Gavin Lambert, Dr, BakerIDI Heart and Diabetes Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Human Neuro -PCOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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