Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

Hypertension Clinical Trial

Official title:

Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04327934
• Other study ID #: 2000020950
• Secondary ID: R01HL135089-01A1
• Status: Terminated
• Phase: Early Phase 1
• Start date: December 1, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• GnRH antagonist
GnRH antagonist up to 16 days.
• GnRH antagonist + MethylTESTOSTERone 5 MG
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.

Locations

Country	Name	City	State
United States	The John B Pierce Laboratory	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baroreflex Response to LBNP	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
Primary	Free Plasma Testosterone Levels	Concentration of testosterone in blood.	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Primary	Renal Response to LBNP	POST Lower body negative pressure Plasma renin activity	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Primary	Renal Responses to LBNP	PRE lower body negative pressure Plasma renin activity	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Primary	Resting Systolic Blood Pressure	Blood pressure prior to lower body negative pressure	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Primary	Final Systolic Blood Pressure	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
Primary	Resting Sympathetic Activity	Total sympathetic nerve activity	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Primary	Sympathetic Baroreflex	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	Aldosterone	Plasma aldosterone concentration	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Secondary	Renal Responses	P[ACE], angiotensin-converting enzyme	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone