Compromised Microcirculation in Women With Polycystic Ova... | NCT00757185

Studies
Compromised Microcirculation in Women With Polycystic Ovary Syndrome

NCT00757185

Sponsor

Yale University

Status

Completed

Last Update Posted

Jul 4, 2016Estimated

Enrollment

28Actual

Phase

Early Phase 1

Conditions

Polycystic Ovary Syndrome

Interventions

ganirelix acetate
methyl testosterone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21HL093450	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Apr 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Sep 22, 2008

First Submission Date that Met QC Criteria

Sep 22, 2008

First Posted Date

Sep 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2016

Last Update Posted Date

Jul 4, 2016Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	GNRH antagonist alone	Drug: ganirelix acetate
2	Experimental	GnRH with Testosterone	Drug: methyl testosterone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ganirelix acetate	Drug	GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin blood flow and cutaneous vascular conductance		6 non consecutive days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Conditions that would preclude safe use of hormones

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nina Stachenfeld, PhD	John B. Pierce Laboratory	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John B. Pierce Laboratory		New Haven	Connecticut	06520	United States

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C061018	ganirelix
D008777	Methyltestosterone

Ancestor Terms

ID	Term
D013739	Testosterone
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes

Browse Leaves

Not provided

Browse Branches

Not provided