Polycystic Ovary Syndrome - Improving Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Group Type ACTIVE_COMPARATOR

Moxonidine

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Encapsulated lactose powder

Interventions

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Moxonidine

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

Intervention Type DRUG

Placebo

Encapsulated lactose powder

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes