Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Early Phase 1

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: ganirelix acetate; Drug: methyl testosterone

• Registration Number: NCT00757185
• Lead Sponsor: Yale University

Brief Summary

The scientific aims of the study are to determine how peripheral microcirculatory responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local heating and to determine the mechanism for testosterone effects on peripheral microcirculatory responsiveness in women with PCOS.

Detailed Description

In these studies, we propose to use the skin as a relatively non-invasive model to examine cardiovascular and endothelial function in obese women with and without PCOS. Data have indicated an important role for testosterone in influencing the peripheral microcirculation. While testosterone can lead to vasodilation in the peripheral microcirculation in both men and in women without PCOS, testosterone appears to induce vasoconstriction in women with PCOS. The differential response between women with and without PCOS, and between men and women may be the result of differential ET-1 actions in the vessel, and regulated by the receptor subtype is involved in these actions.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Primary Completion: 2012-04
• Study Completion: 2012-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• Obese women (18-35) years with and without PCOS

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Exclusion Criteria

• Conditions that would preclude safe use of hormones

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ganirelix acetate	GNRH antagonist alone
2	methyl testosterone	GnRH with Testosterone

Primary Outcome Measures

Name	Time	Method
Skin blood flow and cutaneous vascular conductance	6 non consecutive days

Trial Locations

Locations (1)

John B. Pierce Laboratory; 🇺🇸 New Haven, Connecticut, United States