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
  Purpose

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
Polycystic Ovary Syndrome
Drug: ganirelix acetate
Drug: methyl testosterone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00757185

Locations
United States, Connecticut
John B. Pierce Laboratory
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Nina Stachenfeld, PhD John B. Pierce Laboratory
  More Information

No publications provided

Responsible Party: Nina Stachenfeld, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00757185     History of Changes
Other Study ID Numbers: 0801003437, R21 HL093450
Study First Received: September 22, 2008
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
skin blood flow
microcirculation

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

ClinicalTrials.gov processed this record on September 15, 2014