Trial Outcomes & Findings for To Study Polycystic Ovary Syndrome in Taiwanese Women (NCT NCT01256944)
NCT ID: NCT01256944
Last Updated: 2016-01-13
Results Overview
Using serum total testosterone to represent the severity of hyperandrogenism.
Recruitment status
COMPLETED
Target enrollment
290 participants
Primary outcome timeframe
1 year
Results posted on
2016-01-13
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
220
|
|
Overall Study
COMPLETED
|
70
|
220
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Study Polycystic Ovary Syndrome in Taiwanese Women
Baseline characteristics by cohort
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.3 years old
STANDARD_DEVIATION 4.4 • n=5 Participants
|
26.9 years old
STANDARD_DEVIATION 5.8 • n=7 Participants
|
27.68 years old
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
70 participants
n=5 Participants
|
220 participants
n=7 Participants
|
290 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearUsing serum total testosterone to represent the severity of hyperandrogenism.
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
Total Testosterone
|
1.5 nmol/L
Standard Deviation 0.6
|
2.9 nmol/L
Standard Deviation 1.2
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearBMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
BMI
|
23.4 kg/m2
Standard Deviation 5.2
|
25.9 kg/m2
Standard Deviation 6.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearA fasting serum insulin level of greater than the upper limit of normal for the assay used (approximately 60 pmol/L) is considered evidence of insulin resistance.
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
Fasting Insulin
|
8.3 μIU/ml
Standard Deviation 5.7
|
13.5 μIU/ml
Standard Deviation 14.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearFasting blood sugar (FBS) measures blood glucose after you have not eaten for at least 8 hours. It is often the first test done to check for prediabetes and diabetes. World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L).
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
Fasting Glucose
|
5.0 mmol/L
Standard Deviation 1.0
|
5.1 mmol/L
Standard Deviation 0.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 year2-hour postprandial blood sugar measures blood glucose exactly 2 hours after you start eating a meal. This is not a test used to diagnose diabetes. World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L).
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
Two Hour Glucose
|
5.4 mmol/L
Standard Deviation 1.1
|
6.4 mmol/L
Standard Deviation 2.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearHOMA-IR = \[fasting insulin (in μIU/mL) × fasting glucose (in mg/dL)\]/405.
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)
|
1.9 unitless
Standard Deviation 1.3
|
3.2 unitless
Standard Deviation 3.7
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearHypercholesterolemia was defined as \>6 mmol / L.
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
Cholesterol
|
4.5 mmol/L
Standard Deviation 0.8
|
4.9 mmol/L
Standard Deviation 0.9
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearAbnormal serum triglycerides defined as ≥ 1.7 mmol/L
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
Triglycerides
|
0.8 mmol/L
Standard Deviation 0.5
|
1.1 mmol/L
Standard Deviation 0.9
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearMetabolic syndrome was defined (2005 National Cholesterol Education Program, Adult Treatment Panel III) as the presence of at least three of the following criteria: abdominal obesity (waist circumference \>80 cm in women); serumtriglycerides≥1.7 mmol/L; serumHDL\<1.3 mmol/L; systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg; and fasting plasma glucose ≥7.0 mmol/L.
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
HDL
|
1.4 mmol/L
Standard Deviation 0.5
|
1.3 mmol/L
Standard Deviation 0.4
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearLipid profiles, including total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and sex hormone binding globulin (SHBG). Abnormal LDL was ≧4.14mmol/L.
Outcome measures
| Measure |
Control
n=70 Participants
The normal women
|
PCOS
n=220 Participants
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)
|
Non-obese With PCOS
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
LDL
|
2.6 mmol/L
Standard Deviation 0.6
|
3.0 mmol/L
Standard Deviation 0.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearsImpaired glucose tolerance was defined as two hour glucose levels of 7.8-11.1 mmol/L in the 75 g oral glucose tolerance test. In women with impaired glucose tolerance, the fasting plasma glucose level should be \<7 mmol/L.
Outcome measures
| Measure |
Control
n=110 Participants
The normal women
|
PCOS
n=20 Participants
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)
|
Non-obese With PCOS
n=110 Participants
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
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)
|
Nonb-obese With Control
n=50 Participants
BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI \< 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
|
|---|---|---|---|---|
|
Impaired Glucose Tolerance
|
43 percentage of participants
|
25 percentage of participants
|
10 percentage of participants
|
0 percentage of participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PCOS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ming-I Hsu
Taipei Medical University - WanFang Hospital
Phone: 886-2-2930-7930
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place