- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00757185
Compromised Microcirculation in Women With Polycystic Ovary Syndrome
July 1, 2016 updated by: Yale University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- John B. Pierce Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Obese women (18-35) years with and without PCOS
Exclusion Criteria:
- Conditions that would preclude safe use of hormones
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
GNRH antagonist alone
|
GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days
Other Names:
|
Experimental: 2
GnRH with Testosterone
|
testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Skin blood flow and cutaneous vascular conductance
Time Frame: 6 non consecutive days
|
6 non consecutive days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
September 22, 2008
First Submitted That Met QC Criteria
September 22, 2008
First Posted (Estimate)
September 23, 2008
Study Record Updates
Last Update Posted (Estimate)
July 4, 2016
Last Update Submitted That Met QC Criteria
July 1, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Polycystic Ovary Syndrome
- Syndrome
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Androgens
- Anabolic Agents
- Testosterone
- Ganirelix
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- 0801003437
- R21HL093450 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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