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CompletedNCT01117272Updated Nov 14, 2013

The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women

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. Per ClinicalTrials.gov, last updated 2013-11-14.

Sponsored by Taipei Medical University WanFang Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
474
Ages
15 Years to 45 Years
Sex
Female
01

Study summary

Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder of reproductive-age women. According to Rotterdam 2003 criteria: at least two of three criteria are met, hyperandrogenism, chronic anovulation, and polycystic ovary. PCOS will cause irregular menstrual cycle, infertility, acne, hirsutism, obesity, or/and metabolic syndrome, diabetes that may increase risk of cardiovascular disease.

Hyperprolactinaemia is also a common problem in reproductive aged women. Both hyperprolactinaemia and PCOS had endocrine disorder and irregular menstrual cycle. Investigators hope to collect clinical data from PCOS and prolactinemia patients followed in Wang Fang hospital for many years in endocrinological and metabolical aspects for comparison. Investigators at the same time would like to understand more about other similarities and differences between these two endocrinological dysfunction for future study.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • PCOS
  • hyperprolactinemia
  • obesity
  • hyperandrogenic
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's enrollment of 474 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Taipei Medical University WanFang Hospital is the lead sponsor of 201 studies on the registry; 20 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
No
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

  • PCOM by ultrasound Diagnosis
  • Anovulation, Oligo menses
  • Hyperandrogenism

Exclusion criteria

Exclusion Criteria:

  • Women who had been diagnosed with other etiology that should be excluded in PCOS diagnosis, such as hyperprolactinemia, hypogonadotropic hypogonadism, premature ovarian failure, congenital adrenal hyperplastic, androgen-secreting tumor, Cushing's syndrome, disorders of uterus( such as Asherman's syndrome, Mullerian agenesis), chromosomal anomalies( such as Turner syndrome).
  • Women who did not have sufficient clinical or biochemical records.
  • Girls who had menarche at \<3 years of age and women who were >40 years of age.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
474 participants (actual)

Groups and cohorts

  • PCOS group

    Who met the 2003 Rotterdam criteria.

  • Mild hyperprolactinaemia group

    Who were diagnosed with prolactin levels above the upper limit of normal (24.29 ng/ml) and under 100 ng/ml.

  • Control group

    Without PCOS and with normal prolactin levels.

06

What researchers measure

Primary outcomes

  1. hyperprolactin

    Time frame: Who visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center from April 2004 to June 2007

07

Study locations

1 site
  • Taipei Medical University WanFang Hospital
    Taipei, 116, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01117272
Responsible party
Ming-I Hsu (Attending Doctor, Taipei Medical University WanFang Hospital) — Principal investigator
First posted
May 5, 2010
Start date
May 2009
Primary completion
Feb 2010
Completion
Apr 2010
Last update
Nov 14, 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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