NCT01114659

Brief Summary

Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. This first part of study is determine whether genetic polymorphisms influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and controls. Furthermore, women with PCOS were reported with high risk of cardiovascular disease, the investigators planned to calculate the difference of carotid intima-media thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal control to determine the premature atherosclerosis of women with PCOS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

April 29, 2010

Last Update Submit

December 30, 2013

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • The correlation of PCOS betwwen metabolic and cardiovascular disease.

    Participant were followed for 1 month in study period.

Study Arms (2)

Women with PCOS

Normal Control

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Polycystic Ovary Syndrome(PCOS)

You may qualify if:

  • women at reproductive age
  • women with PCOS and women without PCOS.

You may not qualify if:

  • young women who had their menarche less than 3 years
  • women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University WanFang Hospital

Taipei, Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ming-I Hsu, MD

    Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Doctor

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 3, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations

TW(1)