Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

• Sponsor: Yale University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04327934
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Hypertension	Drug: GnRH antagonist; Drug: GnRH antagonist + MethylTESTOSTERone 5 MG	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
• Actual Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy Control Healthy control participants.	Drug: GnRH antagonist; GnRH antagonist up to 16 days.; Drug: GnRH antagonist + MethylTESTOSTERone 5 MG; GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
Experimental: AE-PCOS Participants with AE-PCOS.	Drug: GnRH antagonist; GnRH antagonist up to 16 days.; Drug: GnRH antagonist + MethylTESTOSTERone 5 MG; GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.

Outcome Measures

Primary Outcome Measures

1. Baroreflex assessment [Up to 3 months]

   forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure

2. Sympathetic response during LBNP [Up to 3 months]

   Catecholamines

3. Systolic blood pressure response to LBNP [Up to 3 months]

   Beat by beat systolic blood pressure (Finometer)

4. Diastolic blood pressure response to LBNP [Up to 3 months]

   Beat by beat diastolic blood pressure (Finometer)

5. Sympathetic Baroreflex Assessment [Up to 3 months]

   Sympathetic Nerve activity (microneurography) during modified Oxford. Measured as MSNA as a function of diastolic blood pressure.

Secondary Outcome Measures

1. Renal response to LBNP [Up to 3 months]

   Plasma renin activity

2. Paced Breathing [Up to 3 months]

   Resting muscle sympathetic activity (MSNA) from nerves (microneurography in microvolts)

3. Baroreflex response [Up to 3 months]

   Valsalva Maneuver. Muscle sympathetic outflow from nerves during small blood pressure changes (microneurography in microvolts)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The John B Pierce Laboratory	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Nina Stachenfeld, PhD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04327934
• Other Study ID Numbers: 2000020950
• First Posted: Mar 31, 2020
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• 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
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Hypertension; Syndrome; Methyltestosterone; Prolactin Release-Inhibiting Factors; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate

Study Results

No Results Posted as of Jun 9, 2022