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Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

ganirelix acetate

methyl testosterone

About this trial

This is an interventional basic science trial for Polycystic Ovary Syndrome focused on measuring skin blood flow, microcirculation

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Conditions that would preclude safe use of hormones

Sites / Locations

John B. Pierce Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

GNRH antagonist alone

GnRH with Testosterone

Outcomes

Primary Outcome Measures

Skin blood flow and cutaneous vascular conductance

Secondary Outcome Measures

Full Information

NCT ID

NCT00757185

First Posted

September 22, 2008

Last Updated

July 1, 2016

Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT00757185

Brief Title

Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Official Title

Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

skin blood flow, microcirculation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

GNRH antagonist alone

Arm Title

Arm Type

Experimental

Arm Description

GnRH with Testosterone

Intervention Type

Drug

Intervention Name(s)

ganirelix acetate

Other Intervention Name(s)

Antagon

Intervention Description

GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days

Intervention Type

Drug

Intervention Name(s)

methyl testosterone

Intervention Description

testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day

Primary Outcome Measure Information:

Title

Skin blood flow and cutaneous vascular conductance

Time Frame

6 non consecutive days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Obese women (18-35) years with and without PCOS Exclusion Criteria: Conditions that would preclude safe use of hormones

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nina Stachenfeld, PhD

Organizational Affiliation

John B. Pierce Laboratory

Official's Role

Principal Investigator

Facility Information:

Facility Name

John B. Pierce Laboratory

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

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Compromised Microcirculation in Women With Polycystic Ovary Syndrome

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