Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

January 4, 2024 updated by: Yale University
Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • The John B Pierce Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Control
Healthy control participants.
GnRH antagonist up to 16 days.
Other Names:
  • Antagon
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
Other Names:
  • Antagon + MethylTESTOSTERone
Experimental: AE-PCOS
Participants with AE-PCOS.
GnRH antagonist up to 16 days.
Other Names:
  • Antagon
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
Other Names:
  • Antagon + MethylTESTOSTERone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baroreflex Response to LBNP
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure. This is an important measure of autonomic control of blood pressure. Indicating the the sensitivity of changes in vessel diameter in response to blood pooling (induced by lower body negative pressure).
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Free Plasma Testosterone Levels
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Concentration of testosterone in blood.
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Renal Response to LBNP
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
POST Lower body negative pressure Plasma renin activity
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Renal Responses to LBNP
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
PRE lower body negative pressure Plasma renin activity
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Resting Systolic Blood Pressure
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Blood pressure prior to lower body negative pressure
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Final Systolic Blood Pressure
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
SBP at the end of lower body negative pressure
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Resting Sympathetic Activity
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Total sympathetic nerve activity
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Sympathetic Baroreflex
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
microneurography, diastolic blood pressure (finipres) This is an important measure of autonomic control of blood pressure. Indicating the the sensitivity of changes in muscle sympathetic nerve activity in response to small changes in blood pressure induced by drug perfusion (modified Oxford).
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aldosterone
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Plasma aldosterone concentration
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Renal Responses
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
P[ACE], angiotensin-converting enzyme
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Nina Stachenfeld, PhD, Yale School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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