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Trial record 88 of 566 for:    "Polycystic Ovary Syndrome"

Compromised Microcirculation in Women With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00757185
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : July 4, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: ganirelix acetate Drug: methyl testosterone Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Compromised Microcirculation in Women With Polycystic Ovary Syndrome
Study Start Date : February 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00757185

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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)
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Principal Investigator: Nina Stachenfeld, PhD John B. Pierce Laboratory

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Responsible Party: Yale University Identifier: NCT00757185     History of Changes
Other Study ID Numbers: 0801003437
R21HL093450 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016

Keywords provided by Yale University:
skin blood flow

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