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| Sponsored by: |
Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00757185 |
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: | Basic Science, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Compromised Microcirculation in Women With Polycystic Ovary Syndrome |
| Estimated Enrollment: | 26 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
GNRH antagonist alone
|
Drug: ganirelix acetate
GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days
|
|
2: Experimental
GnRH with Testosterone
|
Drug: methyl testosterone
testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day
|
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 an 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nina Stachenfeld, PhD | 203 562-9901 ext 219 | nstach@jbpierce.org |
| Contact: Cheryl Leone, MA | 203 562-9901 ext 266 | cleone@jbpierce.org |
| United States, Connecticut | |
| John B. Pierce Laboratory | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: | Nina Stachenfeld, PhD | John B. Pierce Laboratory |
More Information
| Responsible Party: | John B. Pierce Laboratory ( Nina Stachenfeld, PhD ) |
| Study ID Numbers: | 0801003437, R21 HL093450 |
| Study First Received: | September 22, 2008 |
| Last Updated: | September 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00757185 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
skin blood flow microcirculation |
|
Antineoplastic Agents, Hormonal Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Ovarian Diseases Methyltestosterone Cysts Hormones Polycystic Ovarian Syndrome |
Testosterone 17 beta-cypionate Genital Diseases, Female Anabolic Agents Testosterone Ganirelix Polycystic Ovary Syndrome Endocrinopathy Ovarian Cysts Androgens |
|
Gonadal Disorders Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Ovarian Diseases Hormones Genital Diseases, Female Pathologic Processes Syndrome Therapeutic Uses Disease Antineoplastic Agents, Hormonal |
Endocrine System Diseases Methyltestosterone Cysts Pharmacologic Actions Adnexal Diseases Testosterone 17 beta-cypionate Neoplasms Testosterone Anabolic Agents Ganirelix Polycystic Ovary Syndrome Ovarian Cysts Androgens |
