To Study Polycystic Ovary Syndrome in Taiwanese Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, MD, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01256944
First received: December 7, 2010
Last updated: December 8, 2015
Last verified: December 2015
Results First Received: November 28, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Polycystic Ovary Syndrome
Metabolic Syndrome
Cardiovascular Disease

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control The normal women
PCOS

Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:

  1. Oligo- or anovulation
  2. Clinical and/or biochemical signs of hyperandrogenism
  3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)

Participant Flow:   Overall Study
    Control     PCOS  
STARTED     70     220  
COMPLETED     70     220  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control The normal women
PCOS

Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:

  1. Oligo- or anovulation
  2. Clinical and/or biochemical signs of hyperandrogenism
  3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)
Total Total of all reporting groups

Baseline Measures
    Control     PCOS     Total  
Number of Participants  
[units: participants]
  70     220     290  
Age  
[units: years old]
Mean (Standard Deviation)
  28.3  (4.4)     26.9  (5.8)     27.68  (7.1)  
Gender  
[units: participants]
     
Female     70     220     290  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Taiwan     70     220     290  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Testosterone   [ Time Frame: 1 year ]

2.  Primary:   BMI   [ Time Frame: 1 year ]

3.  Primary:   Fasting Insulin   [ Time Frame: 1 year ]

4.  Primary:   Fasting Glucose   [ Time Frame: 1 year ]

5.  Primary:   Two Hour Glucose   [ Time Frame: 1 year ]

6.  Primary:   Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)   [ Time Frame: 1 year ]

7.  Primary:   Cholesterol   [ Time Frame: 1 year ]

8.  Primary:   Triglycerides   [ Time Frame: 1 year ]

9.  Primary:   HDL   [ Time Frame: 1 year ]

10.  Primary:   LDL   [ Time Frame: 1 year ]

11.  Primary:   Impaired Glucose Tolerance   [ Time Frame: 1 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ming-I Hsu
Organization: Taipei Medical University - WanFang Hospital
phone: 886-2-2930-7930 ext 2508
e-mail: hsumigni@yahoo.com.tw


No publications provided


Responsible Party: Ming-I Hsu, MD, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01256944     History of Changes
Other Study ID Numbers: WFH-PCOS-99041
Study First Received: December 7, 2010
Results First Received: November 28, 2013
Last Updated: December 8, 2015
Health Authority: Taiwan: Department of Health