Compromised Microcirculation in Women With Polycystic Ovary Syndrome
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Skin blood flow and cutaneous vascular conductance
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- 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
Arms & Interventions
2
GnRH with Testosterone
Intervention: methyl testosterone (Drug)
1
GNRH antagonist alone
Intervention: ganirelix acetate (Drug)
Outcomes
Primary Outcomes
Skin blood flow and cutaneous vascular conductance
Time Frame: 6 non consecutive days
Secondary Outcomes
No secondary outcomes reported