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Polycystic Ovary Syndrome - Improving Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01504321
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Moxonidine Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve Outcomes
Study Start Date : May 2012
Primary Completion Date : May 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

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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


Locations
Australia, Victoria
Heart Centre, Alfred Hospital
Prahran, Victoria, Australia, 3004
Sponsors and Collaborators
Baker IDI Heart and Diabetes Institute
Investigators
Principal Investigator: Gavin Lambert, Dr BakerIDI Heart and Diabetes Institute
More Information

Responsible Party: Markus Schlaich, Associate Professor, Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01504321     History of Changes
Other Study ID Numbers: Human Neuro -PCOS
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Markus Schlaich, Baker IDI Heart and Diabetes Institute:
Polycystic Ovary syndrome
PCOS
sympathetic nervous system
moxonidine

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Moxonidine
Antihypertensive Agents