- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327934
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
January 4, 2024 updated by: Yale University
Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- The John B Pierce Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Control
Healthy control participants.
|
GnRH antagonist up to 16 days.
Other Names:
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
Other Names:
|
Experimental: AE-PCOS
Participants with AE-PCOS.
|
GnRH antagonist up to 16 days.
Other Names:
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
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.
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
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
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
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
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
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
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
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
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
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
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
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).
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aldosterone
Time Frame: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
Plasma aldosterone concentration
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
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
|
Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nina Stachenfeld, PhD, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
October 17, 2018
First Submitted That Met QC Criteria
March 27, 2020
First Posted (Actual)
March 31, 2020
Study Record Updates
Last Update Posted (Estimated)
February 2, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Hypertension
- Polycystic Ovary Syndrome
- Syndrome
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Androgens
- Anabolic Agents
- Testosterone
- Ganirelix
- Prolactin Release-Inhibiting Factors
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- 2000020950
- R01HL135089-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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