Clinical trial · Interventional
Polycystic Ovary Syndrome - Improving Outcomes
Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve Outcomes
NCT01504321CI-TRIAL-00035607completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moxonidine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active
- interventionNames
- Drug: Moxonidine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Microneurography
- timeFrame
- 3 months
- description
- 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 outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDJewson 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 32847570
- DERIVEDShorakae 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 30548504
- DERIVEDShorakae 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 30410448