Polycystic Ovary Syndrome - Improving Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Baker IDI Heart and Diabetes Institute
Sponsor:
Information provided by (Responsible Party):
Markus Schlaich, Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier:
NCT01504321
First received: January 2, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
Drug: Moxonidine
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Baker IDI Heart and Diabetes Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 42
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504321

Contacts
Contact: Gavin Lambert, Dr 03 8532 1346 gavin.lambert@bakeridi.edu.au
Contact: Carolina Sari, Miss 03 8532 1163 carolina.ikasari@bakeridi.edu.au

Locations
Australia, Victoria
Heart Centre, Alfred Hospital Recruiting
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

No publications provided

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
Study First Received: January 2, 2012
Last Updated: December 16, 2013
Health Authority: Australia: Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Moxonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014