Back to resultsMechanisms of Hypertension in Women With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome, Hypertension
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
GnRH antagonist
GnRH antagonist + MethylTESTOSTERone 5 MG
Sponsored by
About this trial
This is an interventional basic science trial for Polycystic Ovary Syndrome
Eligibility Criteria
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
Sites / Locations
- The John B Pierce Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Healthy Control
AE-PCOS
Arm Description
Healthy control participants.
Participants with AE-PCOS.
Outcomes
Primary Outcome Measures
Baroreflex assessment
forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure
Sympathetic response during LBNP
Catecholamines
Systolic blood pressure response to LBNP
Beat by beat systolic blood pressure (Finometer)
Diastolic blood pressure response to LBNP
Beat by beat diastolic blood pressure (Finometer)
Sympathetic Baroreflex Assessment
Sympathetic Nerve activity (microneurography) during modified Oxford. Measured as MSNA as a function of diastolic blood pressure.
Secondary Outcome Measures
Renal response to LBNP
Plasma renin activity
Paced Breathing
Resting muscle sympathetic activity (MSNA) from nerves (microneurography in microvolts)
Baroreflex response
Valsalva Maneuver. Muscle sympathetic outflow from nerves during small blood pressure changes (microneurography in microvolts)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04327934
Brief Title
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
Official Title
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Hypertension
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Control
Arm Type
Active Comparator
Arm Description
Healthy control participants.
Arm Title
AE-PCOS
Arm Type
Experimental
Arm Description
Participants with AE-PCOS.
Intervention Type
Drug
Intervention Name(s)
GnRH antagonist
Intervention Description
GnRH antagonist up to 16 days.
Intervention Type
Drug
Intervention Name(s)
GnRH antagonist + MethylTESTOSTERone 5 MG
Intervention Description
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
Primary Outcome Measure Information:
Title
Baroreflex assessment
Description
forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure
Time Frame
Up to 3 months
Title
Sympathetic response during LBNP
Description
Catecholamines
Time Frame
Up to 3 months
Title
Systolic blood pressure response to LBNP
Description
Beat by beat systolic blood pressure (Finometer)
Time Frame
Up to 3 months
Title
Diastolic blood pressure response to LBNP
Description
Beat by beat diastolic blood pressure (Finometer)
Time Frame
Up to 3 months
Title
Sympathetic Baroreflex Assessment
Description
Sympathetic Nerve activity (microneurography) during modified Oxford. Measured as MSNA as a function of diastolic blood pressure.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Renal response to LBNP
Description
Plasma renin activity
Time Frame
Up to 3 months
Title
Paced Breathing
Description
Resting muscle sympathetic activity (MSNA) from nerves (microneurography in microvolts)
Time Frame
Up to 3 months
Title
Baroreflex response
Description
Valsalva Maneuver. Muscle sympathetic outflow from nerves during small blood pressure changes (microneurography in microvolts)
Time Frame
Up to 3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Obese Insulin Resistant (IR) women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Stachenfeld, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The John B Pierce Laboratory
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
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Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
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