Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

Yale University

Status and phase: Terminated; Early Phase 1

Conditions: Hypertension; Polycystic Ovary Syndrome

Treatments: Drug: GnRH antagonist; Drug: GnRH antagonist + MethylTESTOSTERone 5 MG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04327934

R01HL135089-01A1 (U.S. NIH Grant/Contract)

2000020950

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Healthy Control

Active Comparator group

Description:

Healthy control participants.

Treatment:

Drug: GnRH antagonist + MethylTESTOSTERone 5 MG

Drug: GnRH antagonist

AE-PCOS

Experimental group

Description:

Participants with AE-PCOS.

Treatment:

Drug: GnRH antagonist + MethylTESTOSTERone 5 MG

Drug: GnRH antagonist