Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: methyl testosterone; Drug: ganirelix acetate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00757185

0801003437

R21HL093450 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Conditions that would preclude safe use of hormones

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

1

Experimental group

Description:

GNRH antagonist alone

Treatment:

Drug: ganirelix acetate

2

Experimental group

Description:

GnRH with Testosterone

Treatment:

Drug: methyl testosterone