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Polycystic Ovary Syndrome - Improving Outcomes

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Moxonidine
Placebo
Sponsored by
Baker Heart and Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary syndrome, PCOS, sympathetic nervous system, moxonidine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Heart Centre, Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
January 2, 2012
Last Updated
November 1, 2018
Sponsor
Baker Heart and Diabetes Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01504321
Brief Title
Polycystic Ovary Syndrome - Improving Outcomes
Official Title
Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baker Heart and Diabetes Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary syndrome, PCOS, sympathetic nervous system, moxonidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Moxonidine
Intervention Description
0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Encapsulated lactose powder
Primary Outcome Measure Information:
Title
Microneurography
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood biochemistry measurement
Description
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
Time Frame
3 months
Title
Oral glucose tolerance test
Description
A standard 75g glucose tolerance test will be performed. Venous blood will be taken before and 2 hours after the glucose drink was given.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gavin Lambert, Dr
Organizational Affiliation
BakerIDI Heart and Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Centre, Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32847570
Citation
Jewson J, Lambert E, Sari C, Jona E, Shorakae S, Lambert G, Gaida J. Does moxonidine reduce Achilles tendon or musculoskeletal pain in women with polycystic ovarian syndrome? A secondary analysis of a randomised controlled trial. BMC Endocr Disord. 2020 Aug 26;20(1):131. doi: 10.1186/s12902-020-00610-8.
Results Reference
derived
PubMed Identifier
30548504
Citation
Shorakae S, Jona E, de Courten B, Lambert GW, Lambert EA, Phillips SE, Clarke IJ, Teede HJ, Henry BA. Brown adipose tissue thermogenesis in polycystic ovary syndrome. Clin Endocrinol (Oxf). 2019 Mar;90(3):425-432. doi: 10.1111/cen.13913. Epub 2019 Jan 7.
Results Reference
derived
PubMed Identifier
30410448
Citation
Shorakae S, Lambert EA, Jona E, Ika Sari C, de Courten B, Dixon JB, Lambert GW, Teede HJ. Effect of Central Sympathoinhibition With Moxonidine on Sympathetic Nervous Activity in Polycystic Ovary Syndrome-A Randomized Controlled Trial. Front Physiol. 2018 Oct 25;9:1486. doi: 10.3389/fphys.2018.01486. eCollection 2018.
Results Reference
derived

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Polycystic Ovary Syndrome - Improving Outcomes

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