Compromised Microcirculation in Women With Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nina Stachenfeld, Yale University
ClinicalTrials.gov Identifier:
NCT00757185
First received: September 22, 2008
Last updated: January 14, 2014
Last verified: January 2014

September 22, 2008
January 14, 2014
February 2008
April 2012   (final data collection date for primary outcome measure)
Skin blood flow and cutaneous vascular conductance [ Time Frame: 6 non consecutive days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00757185 on ClinicalTrials.gov Archive Site
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Compromised Microcirculation in Women With Polycystic Ovary Syndrome
Compromised Microcirculation in Women With Polycystic Ovary Syndrome

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Polycystic Ovary Syndrome
  • Drug: ganirelix acetate
    GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days
    Other Name: Antagon
  • Drug: methyl testosterone
    testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day
  • Experimental: 1
    GNRH antagonist alone
    Intervention: Drug: ganirelix acetate
  • Experimental: 2
    GnRH with Testosterone
    Intervention: Drug: methyl testosterone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Conditions that would preclude safe use of hormones
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00757185
0801003437, R21 HL093450
Not Provided
Nina Stachenfeld, Yale University
Yale University
Not Provided
Principal Investigator: Nina Stachenfeld, PhD John B. Pierce Laboratory
Yale University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP