Compromised Microcirculation in Women With Polycystic Ovary Syndrome
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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 |
- Skin blood flow and cutaneous vascular conductance [ Time Frame: 6 non consecutive days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 26 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated 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 |
Inclusion Criteria:
- Obese women (18-35) years with and without PCOS
Exclusion Criteria:
- Conditions that would preclude safe use of hormones
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
No publications provided
| Responsible Party: | Nina Stachenfeld, PhD, John B. Pierce Laboratory |
| ClinicalTrials.gov Identifier: | NCT00757185 History of Changes |
| Other Study ID Numbers: | 0801003437, R21 HL093450 |
| Study First Received: | September 22, 2008 |
| Last Updated: | August 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
skin blood flow microcirculation |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Methyltestosterone Testosterone 17 beta-cypionate Testosterone Testosterone enanthate |
Testosterone undecanoate Ganirelix Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anabolic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Androgens Hormone Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013