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Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00757185
Enrollment
28
Registered
2008-09-23
Start date
2008-02-29
Completion date
2012-12-31
Last updated
2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

skin blood flow, microcirculation

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.

Interventions

GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days

DRUGmethyl testosterone

testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Obese women (18-35) years with and without PCOS

Exclusion criteria

* Conditions that would preclude safe use of hormones

Design outcomes

Primary

MeasureTime frame
Skin blood flow and cutaneous vascular conductance6 non consecutive days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026