DRUG
GnRH antagonist
GnRH antagonist up to 16 days.
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
Status
Terminated
Phase
Early Phase 1
Enrollment
28
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.
Full 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.
Interventions
Treatment arms and agents.
DRUG
GnRH antagonist + MethylTESTOSTERone 5 MG
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
Timeline
From registration to results.
First posted
Mar 31, 2020
Study start
Dec 1, 2017
Primary completion
Jun 30, 2022
Study completion
Jun 30, 2022
Results posted
Feb 2, 2024
Registry updated
Feb 2, 2024
Outcomes
What the study measures.
Primary outcomes
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).
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.
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
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
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
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
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
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).
Secondary outcomes
Aldosterone
Time frame · Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Plasma aldosterone concentration
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 35 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
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 locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
The John B Pierce Laboratory
New Haven, Connecticut, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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