Polycystic Ovary Syndrome - Improving Outcomes

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504321
• Other study ID #: Human Neuro -PCOS
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2018
• Source: Baker IDI Heart and Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Moxonidine
0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months
• Placebo
Encapsulated lactose powder

Locations

Country	Name	City	State
Australia	Heart Centre, Alfred Hospital	Prahran	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Baker IDI Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 months
Secondary	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.	3 months