Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2022-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Control

Healthy control participants.

Group Type ACTIVE_COMPARATOR

GnRH antagonist

Intervention Type DRUG

GnRH antagonist up to 16 days.

GnRH antagonist + MethylTESTOSTERone 5 MG

Intervention Type DRUG

GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.

AE-PCOS

Participants with AE-PCOS.

Group Type EXPERIMENTAL

GnRH antagonist

Intervention Type DRUG

GnRH antagonist up to 16 days.

GnRH antagonist + MethylTESTOSTERone 5 MG

Intervention Type DRUG

GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.

Interventions

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GnRH antagonist

GnRH antagonist up to 16 days.

Intervention Type DRUG

GnRH antagonist + MethylTESTOSTERone 5 MG

GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.

Intervention Type DRUG

Other Intervention Names

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Antagon Antagon + MethylTESTOSTERone

Eligibility Criteria

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Inclusion Criteria

* Clinical Diagnosis of Polycystic Ovary Syndrome
* Able to inject study drug
* Able to swallow pills

Controls:

-Diagnosis of Insulin resistance

* Males

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes