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CompletedNCT01114633Updated Nov 6, 2013

Obesity and Clinical Presentation of Hyperandrogenism

An observational study in Polycystic Ovary Syndrome, sponsored by Taipei Medical University WanFang Hospital. Completed at 1 site in Taiwan. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-06.

Sponsored by Taipei Medical University WanFang Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
46
Ages
15 Years to 45 Years
Sex
Female
01

Study summary

Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation, amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are potentially dangerous in women health. Early diagnosis and prevention is very important to the PCOS patients.

Obesity is the most potential risk of threat to health of populations. There is a major impact of obesity on the PCOS related disorders. Insulin resistance and distribution of adipose tissue were thought to be the important risk factors of cardiovascular and metabolic syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific medical team. The investigators recently published in "Fertility and Sterility" about the clinical presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence (30%) in Taiwanese PCOS women than that previous reported (65-80%) in theWestern women. It is important to know that some clinical presentation of PCOS might have ethic variance. Insulin resistance was reported as another candidate that might have ethic variance. The investigators had reported about 40% women in PCOS women were obese, it is similar with previous literature reported. Obesity is a major factor that could be controlled during the treatment of PCOS.Weight reduction is one of our methods in PCOS treatment. The progressive results for obese PCOS women would be facing the risks of diabetes and metabolic syndrome. The investigators thought like to evaluate the benefit of weight reduction program to the prognosis of obese women with PCOS.

Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of cardiovascular disease, the investigators would like to know the role of EPC to predict metabolic syndrome in women with PCOS. Wan-Fang hospital has a professional team in PCOS treatment and research which including gynecological endocrinologist, cardiologist, medical endocrinologist, specialist in weight reduction. This team had been working well for more that 4 years.

The investigators hope that we can make a contribution to the study and treatment of PCOS in Taiwan.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • PCOS
  • Acne
  • Hirsutism
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's enrollment of 46 is below the median of 106 across 229 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Taipei Medical University WanFang Hospital is the lead sponsor of 200 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Polycystic Ovary Syndrome(PCOS)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acne and/or hirsutism

Exclusion criteria

Exclusion Criteria:

  • Male
  • Menopause
  • Tumor
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
46 participants (actual)
06

Study locations

1 site
  • Taipei Medical University WanFang Hospital
    Taipei, Taiwan 116, Taiwan
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01114633
Responsible party
Ming-I Hsu (Attending Doctor, Taipei Medical University WanFang Hospital) — Principal investigator
First posted
May 3, 2010
Start date
Jun 2009
Primary completion
Apr 2010
Completion
Jun 2010
Last update
Nov 6, 2013

Study contacts

Ming-I Hsu, MD
principal investigator · Taipei Medical University WanFang Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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