Polycystic Ovary Syndrome - Improving Outcomes

Baker Heart and Diabetes Institute

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo; Drug: Moxonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01504321

Human Neuro -PCOS

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Treatment:

Drug: Moxonidine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo