Trial · NCT04327934

Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

NCT04327934, Early phase 1, Terminated, Yale University; results first posted 2024-02-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome. Trials, record NCT04327934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04327934

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
NCT number: NCT04327934
Status: Terminated
Phases: Early phase 1
Enrollment: 28 participants, actual
Lead sponsor: Yale University
Conditions: Polycystic Ovary Syndrome, Hypertension
Interventions: GnRH antagonist, GnRH antagonist + MethylTESTOSTERone 5 MG
First posted: 2020-03-31
Last updated: 2024-02-02
Results first posted: 2024-02-02
Limitations and caveats: Our primary limitation was stoppage due to Covid (our laboratory was forced to close). We also had a very challenging time recruiting subjects when we reopened after the three-month closure under new rules. Subjects who had been enrolled did not return, and new subjects were difficult to recruit. Thus, we were not able to complete all arms of the planned study. We were able to answer our primary questions regarding autonomic function in women with PCOS.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Baroreflex Response to LBNP	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		Arbitrary Units/Beat/mmHg	MEAN
PRIMARY	Free Plasma Testosterone Levels	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		mg/dL	MEAN
PRIMARY	Renal Response to LBNP	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		ng/mL ANG/hour	MEAN
PRIMARY	Renal Responses to LBNP	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		ng/mL ANG/hour	MEAN
PRIMARY	Resting Systolic Blood Pressure	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone	Systolic Blood Pressure	mm Hg	MEAN
PRIMARY	Final Systolic Blood Pressure	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		mm Hg	MEAN
PRIMARY	Resting Sympathetic Activity	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		burst/100 heart beats	MEAN
PRIMARY	Sympathetic Baroreflex	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		Gain (bursts/100 heart beats/ mm Hg)	MEAN
SECONDARY	Aldosterone	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		pg/mL	MEAN
SECONDARY	Renal Responses	Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone		µg/L	MEAN

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Baroreflex Response to LBNP	Healthy Control	Baseline	0.98	Standard Deviation 1.35	Arbitrary Units/Beat/mmHg
Baroreflex Response to LBNP	AE-PCOS	Baseline	1.36	Standard Deviation 0.96	Arbitrary Units/Beat/mmHg
Baroreflex Response to LBNP	Healthy Control	GnRH antagonist	1.9	Standard Deviation 3.0	Arbitrary Units/Beat/mmHg
Baroreflex Response to LBNP	AE-PCOS	GnRH antagonist	4.28	Standard Deviation 6.51	Arbitrary Units/Beat/mmHg
Baroreflex Response to LBNP	Healthy Control	GnRH antagonist with GnRH + Testosterone	0.68	Standard Deviation 0.65	Arbitrary Units/Beat/mmHg
Baroreflex Response to LBNP	AE-PCOS	GnRH antagonist with GnRH + Testosterone	1.46	Standard Deviation 0.76	Arbitrary Units/Beat/mmHg
Free Plasma Testosterone Levels	Healthy Control	Baseline	0.76	Standard Deviation 0.57	mg/dL
Free Plasma Testosterone Levels	AE-PCOS	Baseline	2.72	Standard Deviation 1.13	mg/dL
Free Plasma Testosterone Levels	Healthy Control	GnRH	0.67	Standard Deviation 0.39	mg/dL
Free Plasma Testosterone Levels	AE-PCOS	GnRH	1.06	Standard Deviation 0.31	mg/dL

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Healthy Control	14
Overall Study	STARTED	AE-PCOS	14
Overall Study	COMPLETED	Healthy Control	7
Overall Study	COMPLETED	AE-PCOS	9
Overall Study	NOT COMPLETED	Healthy Control	7
Overall Study	NOT COMPLETED	AE-PCOS	5

Source ClinicalTrials.gov

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	non serious adverse event	Musculoskeletal and connective tissue disorders	Healthy Control	1	14	1
other	non serious adverse event	Musculoskeletal and connective tissue disorders	AE-PCOS	0	14	0
other	non serious adverse event	Immune system disorders	Healthy Control	0	14	0
other	non serious adverse event	Immune system disorders	AE-PCOS	1	14

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Healthy Control	0	14
Total, all-cause mortality	AE-PCOS	0	14
Total, other adverse events	Healthy Control	1	14
Total, other adverse events	AE-PCOS	1	14
Total, serious adverse events	Healthy Control	0	14
Total, serious adverse events	AE-PCOS	0	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42294856	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL135089	Mechanisms of hypertension in women with polycystic ovary syndrome	STACHENFELD, NINA; RECKELHOFF, JANE F	JOHN B. PIERCE LABORATORY, INC.	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2018 to 2021

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Healthy Control vs AE-PCOS: deaths from any cause	Trial comparisons
Healthy Control vs AE-PCOS: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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