Polycystic Ovary Syndrome - Improving Outcomes

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01504321

Enrollment

Registered

2012-01-05

Start date

2012-05-31

Completion date

2015-12-31

Last updated

2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary syndrome, PCOS, sympathetic nervous system, moxonidine

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.

Interventions

DRUGMoxonidine

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

DRUGPlacebo

Encapsulated lactose powder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Microneurography	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

Measure	Time frame	Description
Blood biochemistry measurement	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
Oral glucose tolerance test	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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026