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Compromised Microcirculation in Women With Polycystic Ovary Syndrome

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University Identifier:
First received: September 22, 2008
Last updated: July 1, 2016
Last verified: July 2016
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.

Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: ganirelix acetate
Drug: methyl testosterone
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Skin blood flow and cutaneous vascular conductance [ Time Frame: 6 non consecutive days ]

Enrollment: 28
Study Start Date: February 2008
Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
GNRH antagonist alone
Drug: ganirelix acetate
GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days
Other Name: Antagon
Experimental: 2
GnRH with Testosterone
Drug: methyl testosterone
testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day

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.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Conditions that would preclude safe use of hormones
  Contacts and Locations
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Please refer to this study by its identifier: NCT00757185

United States, Connecticut
John B. Pierce Laboratory
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Nina Stachenfeld, PhD John B. Pierce Laboratory
  More Information

Responsible Party: Yale University Identifier: NCT00757185     History of Changes
Other Study ID Numbers: 0801003437
R21HL093450 ( US NIH Grant/Contract Award Number )
Study First Received: September 22, 2008
Last Updated: July 1, 2016

Keywords provided by Yale University:
skin blood flow

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on April 24, 2017