Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.

Detailed Description
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Our scientific premise is that in AE-PCOS women, the androgen-dominant hormonal milieu causes BP increases via sympathetic activation, vasoconstriction and renal sympathetic nervous system activation. Moreover, this androgen-dominant milieu increases BP via activation of the renin-angiotensin system.

Official Title
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Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome, Hypertension

Intervention / Treatment
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* Drug: GnRH antagonist
* Drug: GnRH antagonist + MethylTESTOSTERone 5 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Diagnosis of Polycystic Ovary Syndrome Able to inject study drug Able to swallow pills Controls: -Diagnosis of Insulin resistance Exclusion Criteria: Any woman that does not fit the inclusion criteria Males

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Control<br>Healthy control participants. | Drug: GnRH antagonist<br>* GnRH antagonist up to 16 days.<br>Drug: GnRH antagonist + MethylTESTOSTERone 5 MG<br>* GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.<br>|
| Experimental: AE-PCOS<br>Participants with AE-PCOS. | Drug: GnRH antagonist<br>* GnRH antagonist up to 16 days.<br>Drug: GnRH antagonist + MethylTESTOSTERone 5 MG<br>* GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baroreflex assessment | forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure | Up to 3 months | 
| Sympathetic response during LBNP | Catecholamines | Up to 3 months | 
| Systolic blood pressure response to LBNP | Beat by beat systolic blood pressure (Finometer) | Up to 3 months | 
| Diastolic blood pressure response to LBNP | Beat by beat diastolic blood pressure (Finometer) | Up to 3 months | 
| Sympathetic Baroreflex Assessment | Sympathetic Nerve activity (microneurography) during modified Oxford. Measured as MSNA as a function of diastolic blood pressure. | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal response to LBNP | Plasma renin activity | Up to 3 months | 
| Paced Breathing | Resting muscle sympathetic activity (MSNA) from nerves (microneurography in microvolts) | Up to 3 months | 
| Baroreflex response | Valsalva Maneuver. Muscle sympathetic outflow from nerves during small blood pressure changes (microneurography in microvolts) | Up to 3 months |