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GnRH Antagonist

GnRH antagonist for Polycystic Ovary Syndrome

Phase < 1
Waitlist Available
Led By Nina Stachenfeld, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, assessed at 7 days of gnrh, assessed at 16 days gnrh+ 5 days of testosterone
Awards & highlights

Study Summary

This trial found that women with AE-PCOS are more likely to have hypertension than women without it.

Eligible Conditions
  • Polycystic Ovary Syndrome
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, assessed at 7 days of gnrh, assessed at 16 days gnrh+ 5 days of testosterone
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, assessed at 7 days of gnrh, assessed at 16 days gnrh+ 5 days of testosterone for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baroreflex Response to LBNP
Final Systolic Blood Pressure
Free Plasma Testosterone Levels
+5 more
Secondary outcome measures
Aldosterone
Renal Responses

Side effects data

From 2009 Phase 3 trial • 682 Patients • NCT00696878
18%
Procedural pain
9%
Headache
7%
Abortion spontaneous
7%
Pelvic pain
5%
Pelvic discomfort
1%
Ectopic pregnancy
1%
Ovarian hyperstimulation syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Corifollitropin Alfa 150 µg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AE-PCOSExperimental Treatment2 Interventions
Participants with AE-PCOS.
Group II: Healthy ControlActive Control2 Interventions
Healthy control participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GnRH antagonist
2017
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,185 Total Patients Enrolled
8 Trials studying Polycystic Ovary Syndrome
1,888 Patients Enrolled for Polycystic Ovary Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,829 Total Patients Enrolled
5 Trials studying Polycystic Ovary Syndrome
88 Patients Enrolled for Polycystic Ovary Syndrome
Nina Stachenfeld, PhDPrincipal InvestigatorYale School of Medicine
4 Previous Clinical Trials
181 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
28 Patients Enrolled for Polycystic Ovary Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
2017. "Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04327934.
~4 spots leftby Apr 2025
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