NCT01504321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 2, 2018

Status Verified

November 1, 2018

Enrollment Period

3 years

First QC Date

January 2, 2012

Last Update Submit

November 1, 2018

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary syndromePCOSsympathetic nervous systemmoxonidine

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (2)

  • Blood biochemistry measurement

    3 months

  • Oral glucose tolerance test

    3 months

Study Arms (2)

Active

ACTIVE COMPARATOR
Drug: Moxonidine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MoxonidineDRUG

0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months

Active
PlaceboDRUG

Encapsulated lactose powder

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Centre, Alfred Hospital

Prahran, Victoria, 3004, Australia

Location

Related Publications (3)

  • 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.

    PMID: 32847570DERIVED

  • 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.

    PMID: 30548504DERIVED

  • 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.

    PMID: 30410448DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

moxonidine

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Gavin Lambert, Dr

    BakerIDI Heart and Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 5, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

November 2, 2018

Record last verified: 2018-11

Locations

AU(1)