NCT04327934 is a EARLY_PHASE1 clinical trial of GnRH antagonist in Polycystic Ovary Syndrome, sponsored by Yale University.

Who is sponsoring NCT04327934?

NCT04327934 is sponsored by Yale University.

What drugs are being tested in NCT04327934?

Interventions in NCT04327934: GnRH antagonist, GnRH antagonist + MethylTESTOSTERone 5 MG.

What condition does NCT04327934 study?

NCT04327934 studies Polycystic Ovary Syndrome, Hypertension.

Is NCT04327934 still recruiting?

NCT04327934 is currently terminated. Last updated 2 February 2024.

Are results published for NCT04327934?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-02 · How we verify

NCT04327934

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

Terminated EARLY_PHASE1 Results posted Last updated 2 February 2024

What this trial tests

EARLY_PHASE1 trial testing GnRH antagonist in Polycystic Ovary Syndrome in 28 participants. Terminated before completion.

Timeline

1 December 2017

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	28
Start date	1 December 2017
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across United States

Drugs / interventions tested

GnRH antagonist — full drug profile →
GnRH antagonist + MethylTESTOSTERone 5 MG — full drug profile →

Conditions studied

Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
Hypertension — all drugs for Hypertension →

Sponsor

Yale University

Who can join

Adults 18 to 35, female only, with Polycystic Ovary Syndrome or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Baroreflex Response to LBNP Primary · 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

Group	Value	95% CI
Healthy Control	0.98	± 1.35
AE-PCOS	1.36	± 0.96

GnRH antagonist

Group	Value	95% CI
Healthy Control	1.9	± 3.0
AE-PCOS	4.28	± 6.51

GnRH antagonist with GnRH + Testosterone

Group	Value	95% CI
Healthy Control	0.68	± 0.65
AE-PCOS	1.46	± 0.76

Free Plasma Testosterone Levels Primary · Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone

Concentration of testosterone in blood.

Baseline

Group	Value	95% CI
Healthy Control	0.76	± 0.57
AE-PCOS	2.72	± 1.13

GnRH

Group	Value	95% CI
Healthy Control	0.67	± 0.39
AE-PCOS	1.06	± 0.31

GnRH + Testosterone

Group	Value	95% CI
Healthy Control	1.34	± 0.23
AE-PCOS	2.19	± 0.19

Renal Response to LBNP Primary · 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

Group	Value	95% CI
Healthy Control	1.05	± 0.82
AE-PCOS	1.10	± 0.46

GnRH

Group	Value	95% CI
Healthy Control	0.54	± 0.33
AE-PCOS	1.14	± 1.31

GnRH+Testosterone

Group	Value	95% CI
Healthy Control	0.83	± 0.71
AE-PCOS	1.36	± 1.51

Renal Responses to LBNP Primary · 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

Group	Value	95% CI
Healthy Control	0.53	± 0.48
AE-PCOS	0.85	± 0.97

GnRH

Group	Value	95% CI
Healthy Control	0.42	± 0.21
AE-PCOS	0.79	± 1.24

GnRH + Testosterone

Group	Value	95% CI
Healthy Control	0.63	± 0.43
AE-PCOS	0.76	± 0.75

Resting Systolic Blood Pressure Primary · 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

Group	Value	95% CI
AE-PCOS	128	± 15
Healthy Control	123	± 13

GnRH

Group	Value	95% CI
AE-PCOS	131	± 10
Healthy Control	124	± 16

GnRH +Testosterone

Group	Value	95% CI
AE-PCOS	130	± 12
Healthy Control	121	± 16

Final Systolic Blood Pressure Primary · 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

Group	Value	95% CI
Healthy Control	105	± 21
AE-PCOS	99	± 23

GnRH

Group	Value	95% CI
Healthy Control	109	± 16
AE-PCOS	113	± 12

GnRH + Testosterone

Group	Value	95% CI
Healthy Control	117	± 16
AE-PCOS	121	± 10

Resting Sympathetic Activity Primary · Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone

Total sympathetic nerve activity

Baseline

Group	Value	95% CI
Healthy Control	14.4	± 4.4
AE-PCOS	10.3	± 2.0

GnRH

Group	Value	95% CI
Healthy Control	7.9	± 0.8
AE-PCOS	6.9	± 1.5

GnRH + Testosterone

Group	Value	95% CI
Healthy Control	13.4	± 3.6
AE-PCOS	14.5	± 5.0

Sympathetic Baroreflex Primary · 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

Group	Value	95% CI
Healthy Control	-0.479	± 0.085
AE-PCOS	-0.496	± 0.142

GnRH

Group	Value	95% CI
Healthy Control	-0.468	± 0.101
AE-PCOS	-0.640	± 0.171

GnRH+Testosterone

Group	Value	95% CI
Healthy Control	-0.445	± 0.087
AE-PCOS	-0.487	± 0.124

Aldosterone Secondary · Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone

Plasma aldosterone concentration

Baseline

Group	Value	95% CI
Healthy Control	75.7	± 41.4
AE-PCOS	136.5	± 60.1

GnRH

Group	Value	95% CI
Healthy Control	44.0	± 37.0
AE-PCOS	127.8	± 70.5

GnRH+testosterone

Group	Value	95% CI
Healthy Control	46.1	± 28.6
AE-PCOS	98.7	± 46.6

Renal Responses Secondary · Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone

P\[ACE\], angiotensin-converting enzyme

Baseline

Group	Value	95% CI
Healthy Control	38.2	± 14.7
AE-PCOS	101.9	± 93.4

GnRH

Group	Value	95% CI
Healthy Control	43.4	± 27.3
AE-PCOS	77.7	± 76.5

GnRH + Testosterone

Group	Value	95% CI
Healthy Control	40.6	± 14.1
AE-PCOS	44.2	± 43.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Six to eight weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Healthy Control

Serious: 0/14 (0%)

Deaths: 0/14

AE-PCOS

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (2 terms — click to expand)

Reaction	System	Healthy Control	AE-PCOS
non serious adverse event	Musculoskeletal and connective tissue disorders	—	—
non serious adverse event	Immune system disorders	—	—

Data from ClinicalTrials.gov NCT04327934 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of GnRH antagonist

Trials testing the same drug.

NCT05326087 — Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT · Phase 3 · not yet recruiting
NCT07212712 — The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans · NA · not yet recruiting
NCT06396390 — Comparison of Progestin Primed Ovarian Stimulation (PPOS) vs.GnRH Antagonist Methods on IVF Outcomes · Phase 4 · not yet recruiting
NCT05759871 — Ovarian Stimulation With FSH Alone Versus FSH Plus GnRH Antagonist in an Oocyte Donor/Recipient Programme · Phase 1, PHASE2 · unknown
NCT05447208 — Effect of GH on the Blastocyst Euploid Rate in AMA Patients · Phase 3 · recruiting

Other recruiting trials for Polycystic Ovary Syndrome

Currently open trials in the same condition.

NCT07591246 — Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction · NA · recruiting
NCT07446985 — Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma? · NA · recruiting
NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting

Other Yale University trials

Trials by the same sponsor.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04327934 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 2 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04327934.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04327934

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of GnRH antagonist

Other recruiting trials for Polycystic Ovary Syndrome

Other Yale University trials

Verify against primary sources