NCT00005459

Brief Summary

To investigate whether women with Polycystic Ovary syndrome (PCOS) have evidence of an increased prevalence rate of subclinical atherosclerosis as measured by the presence of plaque, increased intima-medial carotid artery wall thickness and lower brachial artery flow mediated vasodilation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2000

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

July 29, 2016

Status Verified

January 1, 2008

Enrollment Period

5.9 years

First QC Date

May 25, 2000

Last Update Submit

July 28, 2016

Conditions

AtherosclerosisCardiovascular DiseasesHeart DiseasesCarotid Artery DiseasesCoronary DiseasePolycystic Ovary Syndrome

Eligibility Criteria

AgeUp to 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (9)

  • Guzick DS, Talbott EO, Sutton-Tyrrell K, Herzog HC, Kuller LH, Wolfson SK Jr. Carotid atherosclerosis in women with polycystic ovary syndrome: initial results from a case-control study. Am J Obstet Gynecol. 1996 Apr;174(4):1224-9; discussion 1229-32. doi: 10.1016/s0002-9378(96)70665-8.

    PMID: 8623850BACKGROUND

  • Talbott E, Guzick D, Clerici A, Berga S, Detre K, Weimer K, Kuller L. Coronary heart disease risk factors in women with polycystic ovary syndrome. Arterioscler Thromb Vasc Biol. 1995 Jul;15(7):821-6. doi: 10.1161/01.atv.15.7.821.

    PMID: 7600112BACKGROUND

  • Talbott E, Clerici A, Berga SL, Kuller L, Guzick D, Detre K, Daniels T, Engberg RA. Adverse lipid and coronary heart disease risk profiles in young women with polycystic ovary syndrome: results of a case-control study. J Clin Epidemiol. 1998 May;51(5):415-22. doi: 10.1016/s0895-4356(98)00010-9.

    PMID: 9619969BACKGROUND

  • Talbott EO, Guzick DS, Sutton-Tyrrell K, McHugh-Pemu KP, Zborowski JV, Remsberg KE, Kuller LH. Evidence for association between polycystic ovary syndrome and premature carotid atherosclerosis in middle-aged women. Arterioscler Thromb Vasc Biol. 2000 Nov;20(11):2414-21. doi: 10.1161/01.atv.20.11.2414.

    PMID: 11073846BACKGROUND

  • Loucks TL, Talbott EO, McHugh KP, Keelan M, Berga SL, Guzick DS. Do polycystic-appearing ovaries affect the risk of cardiovascular disease among women with polycystic ovary syndrome? Fertil Steril. 2000 Sep;74(3):547-52. doi: 10.1016/s0015-0282(00)00695-6.

    PMID: 10973653BACKGROUND

  • Winters SJ, Talbott E, Guzick DS, Zborowski J, McHugh KP. Serum testosterone levels decrease in middle age in women with the polycystic ovary syndrome. Fertil Steril. 2000 Apr;73(4):724-9. doi: 10.1016/s0015-0282(99)00641-x.

    PMID: 10731532BACKGROUND

  • Talbott EO, Zborowskii JV, Boudraux MY. Do women with polycystic ovary syndrome have an increased risk of cardiovascular disease? Review of the evidence. Minerva Ginecol. 2004 Feb;56(1):27-39.

    PMID: 14973408BACKGROUND

  • Talbott EO, Zborowski JV, Boudreaux MY, McHugh-Pemu KP, Sutton-Tyrrell K, Guzick DS. The relationship between C-reactive protein and carotid intima-media wall thickness in middle-aged women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2004 Dec;89(12):6061-7. doi: 10.1210/jc.2003-032110.

    PMID: 15579759BACKGROUND

  • Talbott EO, Zborowski JV, Rager JR, Boudreaux MY, Edmundowicz DA, Guzick DS. Evidence for an association between metabolic cardiovascular syndrome and coronary and aortic calcification among women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2004 Nov;89(11):5454-61. doi: 10.1210/jc.2003-032237.

    PMID: 15531497BACKGROUND

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesHeart DiseasesCarotid Artery DiseasesCoronary DiseasePolycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMyocardial IschemiaOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Evelyn Talbott

    University of Pittsburgh

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

September 1, 2000

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

July 29, 2016

Record last verified: 2008-01